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Online Resumes with "ISO 13485"



Manufacturing Engineering - 26 years experience; ISO Lead Auditor

Process or Quality Engineering for Manufacturing Facility

Tags for this Online Resume: Manufacturing, Processes, Quality, ISO 9001, ISO 13485, Training

Director of Quality - ISO 13485 - R&D

To work with a company to develop new products.

Tags for this Online Resume: Quality, ISO 13485, FMEA, Director, Polymers, Patent Agent, 13485, Research

Operations and Quality Manager--10 years experience in FDA and ISO 13485 environment

Gain a position that utilizes my strengths in operations or quality, either as an individual contributor to a team or as a team lead.

Quality Assurance Specialist greater Boston area

Extensive experience in Designing, Implementing and monitoring Quality Management Systems such as ISO 9000:2000, ISO 13485:2003, and 21 CFR 820.Additionally, Supervisory experience in the manufacturing and shipment of medical devices within a multi-culture, fast pace, environment. Coordinated, planned and executed activities to assist manufacturing in meeting production schedules and staying within budget. Good understandi...

Goal focused Quality Leader in medical devices and pharmaceuticals

Began career with 10 years with the FDA in the Detroit District office and at the Kalamazoo, MI and Grand Rapids Resident Posts. Conducted inspections at pharmaceutical and medical device companies, conducted investigations and testified in court. I Left for a start-up medical device contract manufacturer where I developed the quality system and initiated 510(k) submissions. I also identified and resolved problems result...

Ideal Companies: Small to large medical device or pharmaceutical companies such as Abbott Laboratories, Baxter, CR Bard, Phillips, Medtronic, Boston Scientific, St. Jude Medical, Johnson & Johnson, Bausch and Lomb.

Tags for this Online Resume: Quality Systems Management, Regulatory Compliance, ISO 9001:2000/ISO 13485:2003, Pharmaceutical GMPs

Clinical Regulatory Affairs

Tags for this Online Resume: regulatory affairs, quality assurance, clinical research associate, cGMP compliance, ISO 13485, NDA, IND, 510K, PMA, SOP, quality audit

Quality Control and Assurance

• Responsible for the quality assurance program, supervising the quality control technicians in performance of duties and implementing, maintaining and modifying the plant quality management system to improve business operating systems and meet the requirements of customer and best practice audits. Assist with the corrective action of quality related problems, start-up of new products/processes and troubleshooting technical...

Tags for this Online Resume: Quality, Assurance, Process capability, Nadcap, AS9100C, ISO9001

Quality Assurance Manager

Quality Assurance Manager

Tags for this Online Resume: Quality Manager, ISO 9001, ISO 13485, Quality Engineer, Lean Manufacturing, Corrective Action

Quality Engineer-10 years experience-ISO13485-21 CFR Part 820

Tags for this Online Resume: Deviations, QMS Documentation, Customer Complaints, Quality Plans, CAPA, Risk Assessment

Quality Coordinator manufacturing, Baltimore Md

To provide a company with a unique set of skills obtained in the Military and honed in a Research and Development firms manufacturing department, while pursuing a satisfying career and long term relationship with an established company.

Tags for this Online Resume: Inspections, Coordinator, ISO 13485, ISO 9001, AS9100, Production

Chemist

Tags for this Online Resume: Chemist, Director of Research and Development, Environmental, ISO 13485, GMP

Quality Assurance Manager- 20 years experience-ISO 9000-ISO 13485

To continue a successful career in Quality Assurance with a forward thinking company and help to make it a world leader in their industry.

Tags for this Online Resume: Quality Manager, ISO 9000, ISO 13485, Electronics, Medical Devices, Military Veteran