To efficiently place opportunity notifications on the Cleveland 

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·        Name of recruiting organization, location, person to contact and contact info.

 

·       Type of industry, product or service, in one or two words.

 

·        Position/job title.

 

·        Brief description of applicant requirements and qualifications, i.e.  skills, education, training, experience certifications.

 

The open job opportunity information can be forwarded to:

            Job Placement Chair: Donna Campbell ( campbell@ohio.usa.com )

            Postings will remain active approximately 60 days, unless otherwise requested.

DATE POSTED

EMPLOYMENT PROVIDER/ RECRUITER

Location

CONTACT

TYPE OF INDUSTRY

POSITION

REQUIREMENTS & QUALIFICATIONS

7/23/2010 Weatherchem Corporation Twinsburg, Ohio www.weatherchem.com

humanresources@weatherchem.com

Manufacturing - Plastics Packaging Quality Auditor Job Responsibilities
 Daily audit of parts including visual inspection and dimensional measurements against a standard. 
 Accurately record data in computer as well as non-computer based systems.
 Timely reporting of non-conformances to the appropriate people.
 Prompt isolation and documentation of non-conforming parts.
 Participate in daily crew meetings by providing QA tracking, parts, and updates. 
 Pass on pertinent QA information that positively directs the manufacturing process and follow-up to verify throughout the day.
 Assist in the hands-on training of operators.
 Carry out assigned tasks as directed by crew supervisor and quality manager.

Prior Experience 
 3 years in an injection molding environment

Skills
 Strong computer
 Organizational
 Good verbal & written communication
 Understanding of ISO 9000 and SPC

Other Requirements
 Flexibility
 Teamwork
 Self-motivated
 Ability to work overtime and/or in other areas when required
 Must be able to lift up to 50 lbs

Education
High school diploma or equivalent
ASQ certification preferred
7/23/2010 Jim Kay & Associates Midwest (confidential) Donna McKinney
Jim Kay & Associates, Inc. donna@jimkayassociates.com 		(confidential) Quality Manager Knowledge of industry and regulatory requirements. 
Bachelor’s degree in engineering or quality.
Experience with consumer products (that plug-in), not automotive.
Ability to talk with engineers and third party laboratories about product requirements. 
Knowledge of AQL testing.
Knowledge of statistics
7/23/2010 Philips Ohio and Maine We will be providing relocation for all of these jobs.
Just apply directly to our career site or e-mail me a resume.
Katie McAuliffe
Recruitment Sourcing Specialist - RA QA Recruitment Philips
katie.mcauliffe@philips.com 		Medical Device Q&R Supplier Assurance Director (67888) Andover, MA Reporting directly to the Head of Q&R 
Develops and maintains a compliant, effective oversight process to ensure Healthcare remains in good standing with 
worldwide regulatory agencies. Provides central oversight and approval of supply policies and procedures to assure and effectiveness within each of the sector function and Business units sourcing activities. Provide guidance of Supplier assurance process and practices required to meet regulatory quality system requirements worldwide. Provide reports and recommendations to the executive leadership including CEO's and SVP's, VP's and Directors on trends and changes in regulations. Monitor external audits and inspection activities by global governmental regulatory authorities and certifying bodies and communicate to the sourcing function for system review.
*
Candidate Profile
*BA/BS degree, at least 20 years experience in a 
global Medical Device company (or related industry), in areas of Audit, Quality Assurance and/or Regulatory Affairs.
*
*Excellent written and verbal skills *Ability and willingness to travel , 40%, domestic and international
7/23/2010 Philips Ohio and Maine We will be providing relocation for all of these jobs.
Just apply directly to our career site or e-mail me a resume.
Katie McAuliffe
Recruitment Sourcing Specialist - RA QA Recruitment Philips
katie.mcauliffe@philips.com 		Medical Device CT/NM Senior Manager Post Market Surveillance - Cleveland Heights, OH
Your Responsibilities:
*Must be able to recognize and determine if a product situation/complaint meets the Medical Device Reporting requirements, Device Vigilance and reporting of these adverse events to the appropriate regulatory authorities.
*Collecting and analyzing customer complaint data to determine trends and 
initiating requests for corrective action to reduce the number customer 
complaints and improve product quality.
*Responsible to manage a small team of dedicated complaint reviewers, 
investigators and data analysis personnel to provide early warning of product 
issues to management.
*Responsible for the management of the product recalls activities.
*Notify FDA and other regulatory authorities of all product recalls as required
*Support design teams as required to identify potential product hazards or 
safety issues.
*Your Profile:
*Bachelors Degree in scientific, health care, nursing or related field or 
equivalent required.
7/23/2010 Philips Ohio and Maine We will be providing relocation for all of these jobs.
Just apply directly to our career site or e-mail me a resume.
Katie McAuliffe
Recruitment Sourcing Specialist - RA QA Recruitment Philips
katie.mcauliffe@philips.com 		Medical Device Director, Quality Compliance (67889) - Andover, MA Reporting directly to the Head of Q&R 
Provides central oversight of audit effectiveness within each off the 
Business units, and assesses compliance to regulatory quality system 
requirements worldwide. Provide reports and recommendations to the executive 
leadership including CEO's and SVP's, VP's and Directors on trends and changes in regulations. Monitor external audits and inspection activities by global governmental regulatory authorities and certifying bodies as well as FDA and other global government regulatory agencies.
Candidate Profile 
*BA/BS degree, at least 20 years experience in a global Medical Device company (or related industry), in areas of Audit, Quality 
*Ability and willingness to travel ~ 40%, domestic and international
Travel Percentage 50
7/23/2010 Phillips Ohio and Maine We will be providing relocation for all of these jobs.
Just apply directly to our career site or e-mail me a resume.
Katie McAuliffe
Recruitment Sourcing Specialist - RA QA Recruitment Philips
katie.mcauliffe@philips.com 		Medical Device Sr. Director, Quality Operations (67890) - Andover, MA Candidate Responsibilities Reporting directly to the Head of Q&R 
Provide central oversight of quality systems, management review effectiveness 
within each off the Business units, and sector functions worldwide. Provide 
reports and recommendations to the executive leadership including CEO's and 
SVP's, VP's and Directors on trends and changes in regulations and quality 
systems practices. Monitor external audits and inspection activities by global governmental regulatory authorities and certifying bodies.

Candidate Profile 
BA/BS degree, at least 20 years experience in a global Medical Device company (or related industry), in areas of quality systems, Quality Assurance, Quality Engineering.

*Ability and willingness to travel ~ 50-60%, domestic and international
Travel Percentage 50
7/15/2010 Validant Paul Huish | Consultant
(t) 415-400-2613 | (f) 415-292-9825 | phuish@validant.com
Validant | One Embarcadero Center Suite 1160 | San Francisco, CA 94111 | www.validant.com 		Assist and provide support for processing, managing, and completing a backlog of Non-Conformance Reports and CAPAs CAPA 1. Extensive experience in the Medical Device Industry and in Medical Device Manufacturing Facilities
2. Experience with Orthopedic Products would be a plus. 
3. Extensive experience with Non-conforming Reports and CAPA's. 
4. Knowledge of root cause investigations with hands-on experience, use and knowledge of common tools utilized to identify root causes of problems or issues
5. Six Sigma Tools that are utilized for investigating and identifying the root cause of a problem using the DMAIC (Define, Measure, Analyze, Improve, Control) Methodology:
6. Good knowledge of CFR 820 
7. Experience in a technical role with Six Sigma Knowledge would be a plus
8. Minimum four (4) year degree in Life Sciences, Engineering, or equivalent disciplines
9. Must have good communication skills
7/14/2010 Step 2 Streetsboro, Ohio Pat Butler
patbutler.step2@yahoo.com
262-785-0900, ext. 225 		Multinational manufacturer and marketer of high quality plastic products for children, home and garden Product Safety Technician Responsible for the inspection, testing and evaluation of product in accordance with applicable standards and customer requirements.
- Perform all work in accordance with corporate and departmental procedures and policies.
- Document and distribute internal test results in accordance with departmental procedures.
- Responsible for the accuracy of internal test records.
- Participate in the resolution of failing test reports by investigating failures, determine root causes and provide recommendations to Manufacturing, Engineering, Sourcing and Purchasing as applicable.
- Participate in New Product Development Reviews.
- Prepare sample submissions for third party testing.
- Coordinate sample requests from Manufacturing and Purchasing.
- Participate on special projects as needed.

Requirements:
- Entry level position—experience preferred 
- Prefer experience in product safety or quality assurance in rotational, blow molded or injection molded plastics.
- Mechanical skills and aptitude using hand held tools such as wrenches, screwdrivers and air tools.
- Effective written and oral communication skills and interpersonal skills.
- Able to read basic measuring instruments such as tape measures, calipers and protractors. 
- Working knowledge of inspection and testing equipment in a laboratory environment a plus.
- Must be able to lift up to 50 pounds.
- Requires minimal travel.
- Microsoft Office and basic computer skills
- Ability to interpret drawings, product specifications and regulatory standards.

7/12/2010 Phillips Healthcare Cleveland Heights, Ohio Katie McAuliffe
Recruitment Sourcing Specialist
978-659-7542
katie.mcauliffe@philips.com 		Medical Device Manufacturing Supplier Engineer • Bachelor’s Degree in Engineering with 4 - 6 years of relevant experience 
• High Level understanding of statistical methods, quality tools and methodologies (8D, CtQ Breakdown, DMAIC, SPC, AQP, FMEA, Control Plan, LEAN) 
• Six Sigma Training (Black Belt) and/or Lean Proficiency preferred 
• Highly motivated, action oriented, persistent towards accomplishing tasks and drives for success 
• Ability to communicate well, oral and written, in English and local language 
• Sense of urgency 
• Cross functional skills and awareness of business requirements 
• Is accurate and delivers quality work 
• Auditing Skills, Auditor Certification a plus
• ASQ Certification a plus
7/7/2010 SSP Fittings Twinsburg, Ohio jobs@sspfittings.com

Or by mail to:
Human Resources
8250 Boyle Parkway
Twinsburg, OH 44087

 Manufacturer of fittings, valves and fabrications Production Supervisor The ideal candidate will possess:
Leadership skills (both one-to-one and team situations - using appropriate interpersonal styles and methods to guide and develop individuals and groups toward goal and task achievement) .
Planning and organization skills for both self and others of time, resources and work activities.
Decision making (ability to provide sound decisions based on logical assumptions, facts and inputs from others), and being decisive (willing to decide and commit oneself).
Communication skills, both verbal and written, including effective listening skills.
Mechanical aptitude and operating knowledge of department tools and equipment
Operating knowledge of Lean Manufacturing principles and methods of application.

Requirements:
3 – 5 years supervisory experience
Two to three years of manufacturing environment 
High-School Degree required; Associates/Bachelor’s degree preferred
Excellent attention to detail, and organizational ability
Ability to handle multiple tasks and meet deadlines

Preferred:
Five years of metal working, manufacturing experience with department-specific equipment
Two or more years in a Lean Manufacturing environment
7/6/2010 Rose Metal Industries Cleveland, Ohio Robert Rose
216-881-3355
bobr@rosemetal.com 		Metal Fabrication Quality Assurance Manager Familiarity with metals, metal fabrication, welding and quality systems; specifically ISO, QS and TS systems and certification requirements.

Ability to read prints. Working knowledge of geometric tolerancing and weld symbols. 

Problem solving skills including experience using 8D, DOE and other tools. 

Ability to program and use CMM machines as well as more basic types of gauges and inspection equipment.

Must be well organized and be able set priorities. Must be extremely detail oriented and posses the internal drive to “run” an accurate and thorough QA department.

Must possess “people skills” to successfully interface with customers as well as motivate internal efficiency and avoid / resolve potential conflicts with production staff.

Ability to create and manage systems appropriate for a small enterprise. Must be comfortable in a “small business” environment and function well in one in which priorities change quickly. 

Must be self driven to continually refine systems in order to keep up with a changing world in which higher and higher standards are the norm.
7/6/2010 Profit Finders Strongsville, Ohio Tom Fabek
440-638-5214
tfabek@profitfinders.net 		Continuous Improvement Consulting Process Engineer Responsibilities

1) Serve as a key member of the Profit Finders management team. Be a thought contributor and bring new ideas to improve our current Value Delivery efforts.
2) Direct day-to-day activities of the Value Delivery Department. Manage, train and coach analysts in the Value Delivery Department.
3) Sign-off on periodic Continuous Improvement Meetings that are conducted by the Value Delivery Department. Lead Continuous Improvement Meetings for key clients.
4) Establish strong relationships with clients. Most Continuous Improvement Meetings are conducted via Internet, but occasionally travel to clients for these meetings.
5) Direct day-to-day activities of the Field Service Technicians who are setting up Profit Finders data collection equipment. Occasionally travel to client factories to set up Profit Finders equipment and/or train new Field Service Technicians. 

Desired Requirements
1) BS Degree in Engineering
2) 3 to 5 years experience as a Process Engineer with a Fortune 500 manufacturer
3) Lean Manufacturing / Quality experience - SSBB Certification (Six Sigma Black Belt)

Must possess requirements
1) Strong communication & interpersonal skills 
2) Strong PC & analytical skills
3) Positive attitude, good team player & enjoys rapid change
4) Ability to travel (up to 50% overnight) & multitask in a fast-paced environment
7/6/2010 Kichler Lighting Cleveland, Ohio Tammy Hendershot @ 216-573-1005 ext. 6750 Light Fixtures QA Engineer

Position reports to the Director of Quality.  Responsible for conducting PFMEA and DFMEA.  Complete PPAP submissions and control plans.  Approve color and aesthetic standards for new product releases.  Interface with Engineering and Product Management on new products.  Analyze RMA and Cost of Quality Data using Pareto Analysis, leading to COQ reduction.  Determine Root Cause and Corrective Action.  Communicate findings on regular basis with Asia Pacific team.  Map current processes and analyze using VSM.  Propose ideas to improve productivity.  Provide leadership to a quality technician.  

Job Requirements: 4 year degree, PPAP, Quality Control Plans, AQL sampling plans, Root Cause and Corrective Action Implementation, Process Mapping, Value Stream Mapping, Basic GD&T, Pareto Analysis, Data mining and analysis, Familiarity with SMD, Solder Reflow, Thermal Profiling, DFMEA/PFMEA

6/18/2010 Affymetrix Warrensville Heights, Ohio www.affymetrix.com Medical Device Quality Assurance Engineer Designs, evaluates and implements Quality Assurance programs and systems for Manufacturing and Quality Control to ensure compliance with regulatory requirements. Responsible for leading the investigation and resolution of assigned quality issues. Works with other QA Engineers, Quality and Manufacturing to create and/or modify methods and procedures to ensure that appropriate tests are conducted and that products, materials, and manufacturing equipment meet required standards. Develops, applies, revises, maintains and leads these activities for quality standards for product and equipment, methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and/or production equipment. Analyzes reports and returned products and recommends corrective action. Prepares documentation for inspection/testing procedures. Performs internal audits to ensure compliance with ISO and QSR procedures. Communicates with customers and suppliers as necessary regarding quality issues. 

Strong team work and communication; must be able to interact effectively with all other site functions. Excellent planning and time management skills. Knowledge of QSR, ISO 13485, and IVDD. Demonstrated knowledge of scientific principles. Requires thorough knowledge of QSR regulations, and applicable international regulatory requirements. Must be able to interact effectively with all other site functions. Must be able to work with other QA Engineers and QA inspectors to resolve issues as applicable. Bachelors degree and 3-5 years experience desired.
6/17/2010 Integris Consulting Group Chicago, IL / Rocky Mount, NC & Clayton, NC Sharon Fitzpatrick
Integris Consulting Group
773-675-2879
sharon.fitzpatrick@integriscg.com 		Medical Device (various) QUALITY JOBS AVAILABLE, Chicago, IL

1. DIRECTOR, VALIDATION
• Lead global validation program including validation systems for equipment, processes, utilities, facilities,
software and instrumentation
• 7-10 years of experience in pharmaceutical and/or medical device industries including experience in operating
systems to write, review and perform validations in the medical industry
2. MANAGER, VALIDATION (3)
• Each manager will lead one of the following functional areas of the global validation program: Process
Validation, Facility & Equipment Validation or Computer System Validation
• 5-7 years experience in medical device or pharmaceuticals with experience in operating systems to write, review
and perform validations in the medical industry
3. DIRECTOR, DRUG QUALITY ENGINEERING
• Lead pharmaceutical quality improvement process to ensure marketed drug products achieve highest
standards of quality throughout product life cycle
• 7-10 years of experience in quality, ideally in drug and/or medical device industries
4. DIRECTOR, DEVICE QUALITY ENGINEERING
• Lead medical device quality improvement process to ensure marketed devices (durable and consumable)
achieve highest standards of quality throughout product life cycle
• 7-10 years of experience in quality, ideally in drug and/or medical device industries
5. DIRECTOR, CORPORATE QUALITY AUDITING
• Lead quality auditing systems (i.e. design and operation) including manufacturing and distribution systems, as
well as those for suppliers and third party manufacturers
• 7-10+ years experience in quality systems in medical device and/or pharmaceutical industries.
6. DIRECTOR, DRUG & BIOLOGICS NEW PRODUCT QUALITY
• Lead new product quality development process to ensure new drug and biologic products achieve highest
standards of quality when introduced to the marketplace
• 7-10 years of experience in quality, ideally in pharmaceutical and/or medical device industries.
• Master’s degree preferred
7. DIRECTOR, DEVICE NEW PRODUCT QUALITY
• Lead new product quality development process to ensure new medical devices (durable and consumable)
achieve highest standards of quality when introduced to the marketplace
• 7-10 years of experience in quality, ideally in pharmaceutical and/or medical device industries.
• Master’s degree preferred
8. DIRECTOR, MICROBIOLOGY & ASEPTIC PROCESSING
• Lead Microbiology and Aseptic Processing technical functions to achieve highest quality through new
processes and continuous improvements
• 7-10 years of experience in quality, ideally in aseptic drug manufacturing
• Master’s degree required
9. DIRECTOR, QUALITY SYSTEMS
• Lead Quality Systems function including document control, change management, CAPA, investigations,
compliance training, etc.
• 7-10 years of experience in quality with a minimum of 3 in quality systems
• Master’s degree preferred
10. DIRECTOR, ANALYTICAL & LABORATORY SUPPORT
• Lead laboratory technical functions to produce highest quality product possible by implementing and
continuously improving analytical and laboratory systems/ processes
• 7-10 years of experience in quality, ideally in the pharmaceutical industry
• Master’s degree required
11. QUALITY ASSURANCE RISK MANAGER
• Establish processes to evaluate and mitigate global quality risks
• 5-7 years quality assurance experience in a healthcare related field
12. MANAGER, MEDICAL DEVICE COMPLAINTS
• Establish and operate systems to gather information about medical device complaints and utilize that information
to improve product quality
• 5-7 years experience in quality systems management including customer complaint analysis and quality
improvement
• Master’s degree preferred
13. MANAGER, DEVICE QUALITY OPERATIONS
• Ensure medical device products are designed, produced and distributed achieving highest standards of quality
and safety
• 5+ years of experience in quality with 3+ years specific to medical devices
14. MANAGER, DRUG QUALITY
• Lead and support quality efforts for drug manufacturing operations
• 5-7 years experience in quality, ideally in pharmaceutical and/ or medical device manufacturing
• Master’s degree preferred
15. MANAGER, GLOBAL QUALITY STANDARDS & REGULATIONS
• Define and communicate quality standards throughout company, including suppliers and third party
manufacturing organizations
• Maintain relationships with regulatory bodies, thought leaders, industry organizations, etc.
• 5-7 years experience in quality systems management including experience working with regulatory agencies
and working globally
• Master’s degree preferred
16. MANAGER, ONE2ONE QUALITY
• Lead quality efforts in support of customers who rely on Hospira to manufacture their products as a third party
• 7-10 years of progressively more responsible positions in drug and/ or medical device manufacturing. Global
experience preferred
• MBA preferred
17. THIRD PARTY QUALITY MANUFACTURING SPECIALIST
• Continuously improve contract manufacturing quality through operation of third party manufacturing programs
• 5-7 years of progressively more responsible positions in drug and/ or medical device manufacturing. Global
experience preferred
18. DIRECTOR, SPECIFICATION & CHANGE CONTROL
• Establish, operate and continuously improve global systems to control changes of guidelines, specifications,
policies and procedures assuring accurate, timely and effective implementation and control of changes
• 7-10 years of change management, regulatory or validation experience in pharmaceutical and/ or medical
device industry
19. CHANGE CONTROL SPECIALIST (3)
• Control specification changes through effective change control processes; act as a corporate resource to
coordinate, review, track and ensure compliance of plant and corporate guidelines
• 2-5 years of change management, regulatory or validation experience in pharmaceutical and/ or medical device
industry or 6-8 years of experience in manufacturing/ technical roles in pharma/ med device
20. QUALITY ENGINEER, DEVICE NEW PRODUCTS (2)
• Ensure new medical devices are designed, developed and operated using appropriate analysis
• 4-7 years of experience in quality/ product design/ product engineering in pharmaceutical and/or medical
device industries
21. QUALITY ENGINEER, QUALITY ASSURANCE SYSTEMS (2)
• Ensure quality systems are designed, developed and operated using appropriate analysis
• 4-7 years experience in quality/ product design/ product engineering preferably in the pharmaceutical and/or
medical device industries
22. QUALITY ENGINEER, DRUG COMPLAINTS & STATISTICS
• Improve quality performance by analyzing customer and internal complaints and implementing process/ product
improvements to assure customer satisfaction
• 4-7 years of experience in quality/ product design/ product engineering preferably in the pharmaceutical and/or
medical device industries
23. QUALITY ENGINEER, DRUG NEW PRODUCT QUALITY
• Lead and support new drug product development processes to ensure new drug and biologic products are
developed using appropriate engineering analysis and processes
• 4-7 years of experience in quality/ product design/ product engineering preferably in the pharmaceutical and/or
medical device industries
24. QUALITY ENGINEER, SOFTWARE RELIABILITY
• Ensure software products are developed using appropriate engineering analysis & processes
• 4-7 years experience in software quality, product design or produce engineer, preferably in medical device
industry
25. QUALITY ENGINEER, CONSUMABLE MEDICAL DEVICES
• Ensure consumable medical devices are developed using appropriate engineering analysis & processes
• 7+ years of experience in new product development/quality with experience in design controls, risk
management & validation including team leadership
• CQE and/or CQA certification desired


QUALITY JOBS AVAILABLE, ROCKY MOUNT, NC & CLAYTON, NC

1. QUALITY ENGINEERS, APQR
• Manage the Annual Product Quality Review program
• 3+ years of experience in pharmaceutical manufacturing/ quality related roles. FDA regulated food and/ or chemical
manufacturing experience also accepted
• Bachelor’s degree required, Master’s degree preferred
• Must have strong technical writing skills
2. COMPLIANCE INVESTIGATORS
• Responsible for helping to determine root cause deviations from approved processes/ procedures in the plant, proposing
corrective and preventative actions to prevent recurrences and driving timely completion of through investigation reports
• 5+ years of experience in quality, manufacturing, engineering or R&D or a combination of education and experience
• Bachelor’s Degree in Science, Engineering or Manufacturing related discipline a plus
• Must have knowledge of cGMP and regulatory requirements
3. MQA MANAGER
• Maintains responsibility for all aspects of plant GMP compliance
• Bachelor’s required; Master’s preferred
4. VALIDATION QUALITY MANAGER
• Manages development & implementation of validation procedures to ensure products meet regulatory agency validation
requirements
• 10+ years of experience & Bachelor’s required
5. LAB ANALYST II
• Performs general wet chemistry analysis, problem solving and technical lab support
• Bachelor’s preferred; Diploma or GED plus experience acceptable
6. SENIOR CQ SPECIALIST
• Responsible for in depth review of all equipment and systems within the lab while assisting with remediation efforts
• Bachelor’s plus 6 years experience or Master’s plus 4 years experience required
7. REMEDIATION PROJECT LEADER
• Responsible for developing and implementing a comprehensive remediation plan, tracking FDA commitments and
ensuring compliance to dates, implementing the seven initiatives
• Bachelor’s plus 8-10 years experience or Mater’s plus 6-8 years experience required
8. REMEDIATION COORDINATOR
• Responsible for developing systems to support APQR generation and management review program
• Bachelor’s and 5-7 years of experience required
9. COMPLIANCE TECHNICIANS
• Responsible for supporting the ongoing Annual Product Quality Review (APQR) program
• Bachelor’s and 3-5 years experience required
10. CAPA COORDINATOR
• Monitor Corrective and Preventative Actions (CAPA), communicating status to all departments
• Review and evaluate completion documentation, status reports and extension requests to ensure they are successfully
resolved on schedule
• Develop metrics and design reports for process monitoring
• Coordinate execution of monthly management review meetings and quarterly reviews with corporate management
• Bachelor’s degree and 3-5 years experience required
11. GMP OFFICER
• Responsible for compiling and assessing product quality data, assisting in coordination of site reviews for customer
complaints, hosting and completing audits internally and externally
12. CHEMISTRY SUPERVISOR
• Supervises lab techs within the Chem Lab
• Must have in depth knowledge of technical procedures and compliance/ quality documentation
• Bachelor’s required
• 2-3 years experience preferred
13. BATCH RELEASE SPECIALIST
• Quality/ validation review of laboratory documentation
• Bachelor’s degree and 2+ years of quality auditing experience
14. REGULATORY COMPLIANCE TECHNICIAN
• Technical support and service to plant QA operations
• Expert in product complaints analysis, CAPA, CAIR (Clean Air Interstate Rule) Process & Manufacturing Process
Investigation
• Bachelor’s required; 3-5 years of experience desired
15. COMPLIANCE SPECIALIST
• Monitors & analyzes product quality data
• Participates in audits including manufacturing, laboratories, utilities, quality areas, engineering and training
• Bachelor’s required; 3-5 years of experience desired
16. QA PROJECT SPECIALIST
• Works in quality documentation department on training, auditing and approval of documentation
• Bachelor’s and 2+ years experience required
17. QUALITY ENGINEER
• Implements corporate and regulatory compliance in the manufacturing facility
• Conducts and writes formal investigation reports
• Bachelor’s and 2-5 years experience required
18. QUALITY SPECIALIST – PARTICULATE (CHEMISTRY LAB)
• Responsible for improvements to the room environment, equipment and training for particulate testing
• Isolate and identify particulate observed in product and participate in particulate investigations to help determine root
cause
19. QUALITY ASSURANCE PROFESSIONAL
• Independent quality review of laboratory data (Batch Release Specialist)
20. VALIDATION QUALITY ENGINEER
• Quality review and approval of validation documents
21. TECHNICAL SERVICES QA REVIEW
22. TECHNICAL SERVICES MANAGER
• Responsible for both QC (chemical quality) and BQ (biological quality) lab operations
23. CHEMISTRY LAB SUPERVISOR
• Directs up to 10 analysts that support the manufacturing operation including management of employee issues such as
disciplinary action, performance reviews and developmental goals
• 5+ years of laboratory experience and 3+ years of supervisory experience
• Familiarity with cGMP, cGLP and operation/ maintenance of lab equipment

6/15/2010 Bridgeway Search Group, Inc. Northern Ohio Jim Bollenbacher
Practice Leader - Life Sciences
Office 216.621.9700 ext.105
 Medical Device Director, Regulatory Affairs Summary: 
The mission of the Regulatory Affairs Submissions and Registrations function is to implement efficient and effective processes to initially obtain and then maintain registration approvals to market products in designated countries in support of global business plans. This includes determining registration and/submission requirements in the various markets, identifying the documentation needed to meet the identified requirements, and working closely with corporate, domestic and international staff, distributors, regulatory consultant contractors and various U.S. and foreign government agencies to prepare and submit required documents, while using electronic record-keeping tools according to departmental policy. This group identifies and supports Regulatory Compliance needs in all markets.

Essential Job Duties:
Instrumental in the development and implementation of best practices within Regulatory Affairs. 
Review and interpret technical and scientific data to ensure submissions are accurate and regulatory requirements are met. Critically assess the technical strength and completeness of document packages (dossiers, 510(k) s, Technical Files, Minor Modification files); advise improvements to comply with current requirements for particular regulatory authorities. 
Lead staff to achieve international submission/registration/approvals necessary to market products domestically and globally per the business plan. 
Oversee or perform the review and approval of labeling, promotional (advertising), sales materials and technical/scientific publications to ensure that all label formats, product claims and instructions for use are appropriate and consistent with cleared indications for use, product design documentation, and US and international regulations as applicable. 
Provide systems to maintain the accuracy and integrity of departmental records, and assure that all Regulatory staff members maintain paper and electronic submission documents and databases in an accurate, complete and timely manner to ensure prompt and accurate access to company regulatory information. 
Monitor and report to stakeholders on pending and existing submission/registrations to identify potential delays and take action in a timely manner to avoid disruption in product availability. 
Direct the selection and implementation of comprehensive software tools to organize and manage the registration process and apply appropriate sales controls. Ensure that software validation tools are employed as appropriate. 
Provides technical assistance to the Quality Team reviewing validation test protocols as well as performing peer reviews to ensure compliance with industry standards and FDA guidance documents. 
Participate in cGMP compliance audits initiated by FDA, International Governmental agencies, Notified Body BSI and customer inspections.

Education/License Requirements
Bachelor’s degree required, with scientific, engineering, or clinical course of study optimal. 
• Professional certifications and regulatory training certificates in relevant disciplines are desirable. 
• Bilingual skills are a plus, but not required.

Experience Requirements
• Minimum of eight (8) years professional experience, preferably including regulatory affairs, legal or governmental compliance matters, quality systems, internal auditing, applicable scientific or technical functions, and/or healthcare industry experience.
• Expert level of knowledge and demonstrated effective implementation in three or more applicable regulatory specialty area such as the US FDA device clearance process, EU device marketing requirements, FDA QSR/cGMP compliance, Australian, Canadian, or other particular country requirements. 
• Managerial courage to confront difficult issues with the appropriate response and to do so in a timely manner with any/all stakeholders. 
• Self-starter with demonstrated organizational, time management and problem-solving skills as well as proven leadership / role model qualities.
• Experience working on or leading cross-functional teams is desirable.
• Strong oral and written communications skills. 
• Strong interpersonal skills – able to work closely with people at all levels of the organization and with persons from different cultural, language and regional backgrounds to accomplish the assigned job responsibilities. 
• Excellent PC skills including Microsoft Office applications.
6/1/2010 Lubrizol Wickliffe, Ohio www.lubrizol.jobs Chemical Resource Manager

DUTIES/RESPONSIBILITIES:

· Supervise approximately 18 chemists and lab technicians with responsibility for all aspects of     resource management. Provide coaching and timely performance feedback to group members; ensure departmental resources and processes are aligned and prioritized with business needs.
· Support Testing Leadership Team in achieving departmental and divisional goals; collaborate with global staff members on customer issues and division objectives.
· Foster an environment that encourages employees' professional growth and promotes continuous improvement of department operations. Assist employee development through Performance and Career Management process and facilitate cross-training assignments.
· Proactively solicit feedback from key internal customers, other departments and divisions, and ensure their needs are being met.
· Collaborate with department staff and Lubrizol Additives staffing department to recruit individuals into BTS as full-time employees, student interns, and contractors.
· Develop and administer operating and capital budgets for group; work in partnership with staff members to manage overall BTS budgets.
· Communicate effectively to a wide variety of audiences.
· Ensure quality and integrity of laboratory data as well as BTS services and processes.
· Manage ISO 9001:2000 and ISO 17025 quality certifications and support Data Stewardship.
· Provide a safe work environment and leadership on safety initiatives; ensure that all employees work safely and in the spirit of VPP Star and RCMS.
· Lead and manage departmental and divisional projects as needed.
· Up to 15% domestic and international travel.

SKILLS, QUALIFICATIONS, EXPERIENCE, SPECIAL PHYSICAL REQUIREMENTS:
· Bachelor's degree in Engineering, Chemistry or Business.
· Minimum 5 years technical/technical services experience.
· Minimum 1 year experience managing people and/or team leadership.
· Experienced with managing projects and organizing significant volume of work.
· Ability and desire to develop strong people management skills to engage and inspire others and be willing to develop the skills necessary to manage differences and resolve conflicts.
· Excellent verbal /written communication and listening skills
· Demonstrated leadership and flexibility.
· Experienced in prioritizing and managing customer requests.
· Demonstrated ability to solve technical and process-related problems.
· Customer-focused with ability to recognize and adapt to changing business needs.
· Demonstrated interpersonal and conflict management skills.
· Team-oriented, motivated, self-starter.
· Understanding of safe laboratory practices and lab safety programs.
· Ability to travel as required.

CONSIDERED A PLUS:
· Formulating experience.
· Knowledge of data acquisition, upload and reporting.
· Familiarity with Lubrizol chemistry, test methods and processes.
· Familiarity with ASTM methods and ISO certifications.
6/1/2010 Lubrizol Wickliffe, Ohio www.lubrizol.jobs Chemical Research Chemist - Chemical Synthesis Department DUTIES/RESPONSIBILITIES:
· Invent, prepare, and develop new chemical products
· Develop structure-performance relationships
· Perform independent research in a multidisciplinary environment on complex issues
· Utilize advanced chemical knowledge, data, modeling and statistical tools to solve technical challenges
· Work with business teams and/or customers to develop innovative new technology
· Document, interpret and communicate results to colleagues, sponsors and customers
· Follow safe laboratory practices

SKILLS, QUALIFICATIONS, EXPERIENCE:
· Ph.D. in chemistry (organic, inorganic or polymer)
· Experience in the synthesis and characterization of organic, polymeric, inorganic, or organometallic compounds
· Track record of innovative thinking and technical accomplishments
· Strong interpersonal skills
· Ability to work independently and cooperatively in a multidisciplinary environment
· Excellent organizational and communication (written and verbal) skills

CONSIDERED A PLUS:
· Post Doctoral or Industrial experience
6/1/2010 Lubrizol Wickliffe, Ohio www.lubrizol.jobs Chemical Colloid / Rheology Research Scientist DUTIES/RESPONSIBILITIES:
· Apply knowledge of colloid science and rheology to lead and support multi-disciplinary projects toward the development of new products and/or fundamental knowledge
· Communicate and interact with a broad range of internal and external customers through technical reports and presentations
· Promote the capabilities and technical competencies through participation at industry related conferences
· Support the development and application of new testing and characterization techniques
· Perform hands-on research as well as direct and prioritize the work of technical staff
· Participate in the recruitment and training of technical staff
· Follow safe laboratory practices
· Up to 10% domestic and international travel.

SKILLS, QUALIFICATIONS, EXPERIENCE, SPECIAL PHYSICAL REQUIREMENTS:
· PhD or MS degree in chemistry or chemical engineering specializing in colloid science and rheology
· Minimum 2 years of practical experience in colloid science and rheology
· Proven track record of technical publications and presentations in internationally recognized forums
· Good organization and planning skills; ability to handle multiple projects/tasks simultaneously and meet deadlines
· Ability and desire to interact with commercial, production and R&D areas in a team environment to obtain results to move projects toward completion
· Ability to apply logic and scientific concepts in the design of experiments and interpretation of data
· Experience with leading or managing research projects
· Good interpersonal and communication skills
· Good teamwork and leadership skills
· Ability to travel as required

CONSIDERED A PLUS:
· Familiarity with dispersion or emulsion formulation and product development
· Experience with particle sizing and rheological instrumentation
5/28/2010 Gojo Akron, Ohio Send your resume, referencing job number 4478, to:   jobs@gojo.com Pharmaceutical Technical Services Quality Engineer

This position is of a technical services quality engineer nature which employs thorough, accurate and timely engineering practices for identification, analysis, design, development, commercialization of systems and technologies, and equipment and/or processes to meet customer needs.  Evaluates, optimizes and implements technologies, equipment and/or processes with a goal to improve overall business.  Produce and transfer engineering specifications into manufacturable processes for new and improved products through established quality processes throughout the development process.  Requires strong customer interface.

Education and Experience Required 
· 5 plus years professional experience in technical services quality engineering.
· Bachelor’s degree in an Mechanical Engineering field or appropriate technical discipline is preferred
· Demonstrable technical skills including knowledge in product/technology development from concept to commercialization
· DFMEA, Design for Six Sigma (DFSS), Design of Experiments (DoE), Kaizen preferred
· ProE experience preferredData analysis experience – Minitab preferred

5/27/2010 Affymetrix Ohio Fill out application at: www.affymetrix.com Medical Device, Reagent and Chemical Document Control Coordinator

Responsible for release and maintenance of quality documents and data that are used to produce or support the production of the company's various products. Also responsible for ensuring compliance with internal policies and procedures as well as regulatory agencies requirements applicable to the products and documents. Primary focus on change order initiation, change review and approval, component dispositioning, change monitoring, implementation and closure. Also responsible for maintaining hard copy records and storage areas.

Minimum of one year experience in Document Control or related function. Strong team work and communication skills. Database maintenance experience a must. Fundamental working knowledge of quality systems and quality assurance concepts including cGMP. Knowledge and background of PDM and ERP/MRP systems a plus.

Full Time – Regular

Education Required: High School Diploma

Experience: 1 - 3 Years

 

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Last updated: December 09, 2008.