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Online Resumes with " Quality System Regulation QSR "



Accomplished New Product Development & Quality Assurance Manager

� Accomplished, self-starting New Product Development and Quality Assurance engineering manager � Over 10 years of experience in medical device development � Hands-on experience leading product development cycle from concept selection to commercialization in both New Product Development and Quality Assurance management roles, including voice of customer activities, concept selection, design characterization, verification an...

Ideal Companies: Johnson & Johnson, General Electric, Kimberly Clark

Tags for this Online Resume: Quality, New Product Development, Manager, Medical Device, Biomedical, NPD, Engineer, Research , QA, Development, Quality Assurance

Production Supervisor -- 14 years experience

These sentences are to express my interest in the Production Supervisor position based on my skills in administration, leadership, communication, technical, development, performance management, statistical and computer knowledge, and problem solving. I am confident that I would be a great addition to your team. My resume that highlights my knowledge in manufacturing environment is enclosed on medical industry mainly....

Tags for this Online Resume: Production Supervisor

Clinical Research Associate

To obtain a Clinical Research Position in the Minnesota Area.

Tags for this Online Resume: Knowledge of 21 CFR, Quality System Regulation (QSR), Medical Device Reporting, Regulatory Compliance , Regulatory Submissions , ICH GCP Guidelines

Quality Engineer

Summary: John has been an ASQ-certified Quality Engineer and ASQ-certified Quality Auditor and a Philips-Global-certified Lead Auditor with a strong experience within medical device, pharmaceutical and contract packaging companies, while following FDA drug Good Manufacturing Practices, FDA medical device Quality System Regulation, ISO 9001 and ISO 13485 environments. He has a solid understanding with QSR supplier control sy...

Tags for this Online Resume: Compliance, Quality Assurance, Support, Technical Support, Test, Corrective Actions, Medical, Medical Devices, ISO, Audit

Production Supervisor

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, Audit, Corrective Actions, Management, Process Improvement, Technology Transfer, Training, Change Control, Good Manufacturing Practices

Quality Manager - 16 Years of Experience - Near 30038

SUMMARY Highly motivated Quality Professional with over 15 years' combined working knowledge in Quality System Regulations (QSR), Quality Management System (QMS), FDA Inspection Readiness, and Systems Based Auditing with varied cGMP, cGLP, Nonconformance and CAPA Management experience. Experience in regulated environments for Pharmaceutical, Medical Device, Biologics and Bio-Chemical industries. Demonstrated strengths in or...

Tags for this Online Resume: Complaints, NCR, Test, Audit, Facilitator, Green Belt, High Performance Liquid Chromatography (HPLC), Logistics, Quality, Quality Assurance, Corrective action preventive action, steel, mechanical engineer, die cutting, machine operator, electrical engineer, CAPA, Risk Analysis, FMEA, Control Plans

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

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

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