CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "13485"

Aircraft Rigging Assembler

Tags for this Online Resume: Medical Devices, ISO 13485 AS9100 ISO 9001, FDA 820 510(k), Quality Systems Auditor, Quality Systems Author

Senior Scientist - M.S. Biologist, medical diagnostic industry, 20+ years experience. R&D, Manufacturing, Quality Assurance, Technical Support, and Quality Systems.

M.S. Biologist, molecular biology background, medical diagnostic industry. Experienced in R&D, Manufacturing, Quality Assurance, Technical Support, 21 CFR 820, audits, submissions and FDA communications. Proficient in technical reports, documentation, presentations, analytical instrumentation (HPLC, CE, UV-VIS), statistics (JMP, DOE, SPC, specifications), immunoassay development (ELISA, purification, conjugation), test meth...

Tags for this Online Resume: Medical Device, Quality, Auditing, molecular biology, manufacturing, regulatory, Quality/Regulatory, Biologics Manufacturing, MicroBiology/Environmental Monitorrig, Regulatory Affairs

Quality Assurance Manager-30 years experience

Lead quality Assurance activities to a 5 star quality system for compliance to 21CFR, ISO 13485

Tags for this Online Resume: quality, QA, manager, assurance, Quality Assurance, director

quality assurance engineering/management 15 years

I work well in a variety of environments and my objective is to contribute my experience to the success of the business

Tags for this Online Resume: ISO9001:2008, process qualification, 14385, greenbelt certified, regulatory affairs, Process V/V, calibration, 13485 certification, medical device mfg

Product Compliance and Safety Engineer

 Global Product Compliance ( Regulations | Standards)  Safety Engineering ( Medical | ITE)  Quality Assurance ( Design Controls | Risk Management )  QMS Auditor ( 21CFR820 | 13485 | 9001 )  System Design ( Medical | ITE )  Electrical Engineering ( Medical | Safety | EMC | RF )  Manufacturing Engineering ( Medical | DFM )  Test Engineer ( Electrical | EMC )

Tags for this Online Resume: Product Compliance, Safety, QA & QMS Auditor, System Design, Electrical Engineer, Manufacturing Engineer

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

Quality Assurance manager

QUALITY ASSURANCE AND CONTROL MANAGER More than 15 years of achievement and success in QA management and document control Diligent, analytical, and results-oriented QA / QC expert with extensive experience in all aspects of ISO 001:2000, 22000, 1400, 13485, 17205, programs implementation, certification. product, process, and design validation/verification and maintenance; deep understanding of MIL-STD-883, MIL-PRF, and rel...

Tags for this Online Resume: ISO9001:2000, ISO14001 , Quality system , Continual Improvement, Rootcause analysis and implementation, Continual Improvement for product and processes, QA/QC and document control, ISO9008:2000, ISO14001 /Document Control, Quality system/SQF/HACCP/GMP , Sanitation

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