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Online Resumes with "quality system regulations"



Army - 20 Years of Experience - Near 46143

SUMMARY Highly experienced Senior Quality Assurance Manager and Military Veteran with a Security Clearance and 20+ years of proven experience in supply chain management in the Department of Defense, public and private sectors. Possess extensive knowledge in General Management and Supervisor Operations as well as FDA, EMA, OECD and LGS Quality Systems Regulations. Expert in ensuring compliance, identifying and implementing q...

Tags for this Online Resume: Quality Assurance, Test, Customer Service, Quality, Quality Control, Defect Tracking, Help Desk, Information Technology, Manufacturing, Project Leader

Featured Profile

Director of Quality & Regulatory- 22 Years of Experience - Near 45142

Summary Twenty-two years in the Medical Device Manufacturing Field, including 16 years of Director level experience in Quality Managements Systems, Regulatory Affairs and Quality Assurance/Quality Control Activities. Knowledge and professional experience in the following areas: Quality, Engineering and Manufacturing Implemented practical oversight of the following: * ISO13485 * ISO9001 * 21CFR820 (FDA) * ISO14971 Risk Manag...

Ideal Companies: A company with suability, growth and development of their employees.

Tags for this Online Resume: Audit, Engineering, Management, Management Review, Manufacturing, Medical, Quality, Quality Assurance, Quality Control, Regulatory Affairs, steel, medical device, medical devices, Quality Director, Director of Quality & Regulatory

Quality Manager - 20 Years of Experience - Near 92688

Certified Quality Assurance Director with a successful 27 year career in a leading Aerospace, Aviation and Defense industry. Extremely resourceful and self-starter individual with strong analytical, technical and engineering expertise with critical structural and avionics aircraft component design and manufacturing, combined with a wide knowledge of Quality System regulations and QMS implementation support to ISO-9001-2008,...

Tags for this Online Resume: Certified Six Sigma Green belt, Process Improvement, PPAP, SPC, RCCA, CAPA, Project Management, Strategic Planning, Quality Assurance, Test, manufacturing, mechanical engineer, "project management", reliability

Quality Manager

CAREER SUMMARY Ethical, strategic, and transformational leader who engages teams to deliver business results and drive sustainable excellence. Engineering Professional/Lean Six Sigma Black Belt with over 20 years + of experience in Quality, Supplier Quality, Process Engineering, and Kaizen/Lean Manufacturing in Food MFG/HACCP., Good Manufacturing Practices (GMPs), Vertical Pump Application, Global Drive Systems, elevators, ...

Tags for this Online Resume: Process Control, Management, SPC, ISO, Policies and Procedures, Project Management, Project Manager, Quality, Quality Assurance, Quality Management

Director of Quality

CAREER SUMMARY Ethical, strategic, and transformational leader who engages teams to deliver business results and drive sustainable excellence. Engineering Professional/Lean Six Sigma Black Belt with over 20 years + of experience in Quality, Supplier Quality, Process Engineering, and Kaizen/Lean Manufacturing in Food MFG/HACCP., Good Manufacturing Practices (GMPs), Vertical Pump Application, Global Drive Systems, elevators, ...

Tags for this Online Resume: Process Control, ISO, Management, SPC, Black belt, Layout, Policies and Procedures, Project Management, Project Manager, Quality

Operations Manager

Qualifications Profile Lean Green Belt certified professional with career-long expertise in manufacturing operations encompassing quality assurance, project and program management, budget control and allocation, new product development, and strategic planning. Drive operational productivity by integrating Lean principles and leading top-performing teams. Demonstrate adeptness at mentoring and motivating staff and personnel ...

Tags for this Online Resume: Manufacturing, Corrective Actions, Distribution, Electrophoresis, Engineering, Forecasting, Green Belt, Integrate, Inventory, Leadership

Chemical Plant System Operator - 20 Years of Experience - Near 08753

SUMMARY: Over Thirty years' experience in positions of increasing responsibility within the Pharmaceutical and Consumer Divisions of Johnson & Johnson, FMC and Cardinal Healthcare, have provided the opportunity to develop a strong knowledge of FDA, GLP Guidelines, Practices and GMP's as set forward in the Quality System Regulations (Section 820 of The Act). Skilled in both Production Floor, Pilot Plant and Laboratory Enviro...

Tags for this Online Resume: Research, Consumer Products, Medical, Medical Devices, Notebook Computer, Product Development, Wound Care, Quality, Amaps (Mrp/Cim Sw), manufacturing, production

Business Analyst

Qualifications Summary * Over Twenty years' technical writing experience in an enterprise delivery setting. Expertise with end-to-end SDLC/ITIL software development process industries I've worked in include: Electric Utilities, Financial Services, Mining, Food and Beverage, Food and Produce Distribution, Health Imaging, Manufacturing, Oil and Gas, Pharmaceutical IT, Retail and Media Relations * Develop both classroom and we...

Tags for this Online Resume: Documentation, Lightweight Directory Access Protocol, Research, Research and Development, Risk Analysis, Script, Technical Documentation, Test, Test Script, Technical Writing

Principal Engineer

ACCOMPLISHMENTS * Project management of Medical Device right from conceptualisation to manufacture in an ISO/FDA regulated environment. Used suitable stage gates and milestone list to inform key stakeholders about progress of the project. * Planned the project budget, schedule and used change control procedures for controlling changes and preventing scope creep. Negotiated with functional managers for resource allocation an...

Tags for this Online Resume: Medical, Medical Devices, Engineering, Instrumentation, ISO, Management, Cancer, Documentation, Manufacturing, NPI

Life Scientist

SUMMARY: * More than 21 years of excellent experience in Medical Device & Pharmaceutical companies in the area of Process engineering, process Validations, Equipments Qualifications (IQ/OQ/PQ), Process Development Cleaning Validations, New Product Developments, Product and process Technology transfer, Troubleshooting Processes, and in Medical Devices, Product Testing. * Extensive experience in Quality assurances: Auditing, ...

Tags for this Online Resume: Risk Assessment, Quality, Corrective Actions, Process Improvement, Technology Transfer, Audit, Management, Training, Change Control, Good Manufacturing Practices

Life Scientist

SUMMARY: * More than 21 years of excellent experience in Medical Device & Pharmaceutical companies in the area of Process engineering, process Validations, Equipments Qualifications (IQ/OQ/PQ), Process Development Cleaning Validations, New Product Developments, Product and process Technology transfer, Troubleshooting Processes, and in Medical Devices, Product Testing. * Extensive experience in Quality assurances: Auditing, ...

Tags for this Online Resume: Risk Assessment, Quality, Corrective Actions, Process Improvement, Technology Transfer, Audit, Management, Training, Change Control, Good Manufacturing Practices

Department Manager - 20 Years of Experience - Near 00693

Professional validation expert and scientist with up to thirty years of overall experience in the Pharmaceutical Medical Device and Biotechnology Industry. Proficient in manufacturing industry environment including but not limited to facilities utilities solid dosage equipment HVAC water systems chemical plant equipment chemical biotechnology and microbiology instrumentation handling validation (IQ OQ PQ) validation plans c...

Tags for this Online Resume: Quality, Quality Assurance, Project Leader, Project Management, Support, Manufacturing, Test, High Performance Liquid Chromatography (HPLC), Injection Molding, Instrumentation