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Online Resumes with "21CFR820"



Procurement Specialist - 10 years experience - Purchasing and Supply-Chain Management

To further my career in Supply-Chain Mgmt and Purchasing by offering 7 years of process improvements and cost saving strategies. I earned a Bachelors degree in Business Management with woking knowledge of FDA 21CFR820, ISO 13485, and ISO 9001.

Engineering Manager - 10+ years experience - ISO-13485, 21 CFR 820/211, cGMPs, Lean/Six Sigma, Project Management.

To obtain a management level Engineering/Manufactiring/Operations within regulated Medical Devices/Biotech/Pharma/Food Industry where I can utilize past experience in Manufacturing support, process developement, process improvement and product sustaining.

Tags for this Online Resume: Six sigma , Project Management, cGMPs, Lean Manufacturing, APQP, Seasoned Manager

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

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

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...

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Medical Affairs, Regulatory Affairs Associate, Clinical Affairs

Doctor of Medicine recognized with clinical trial expertise in medical device, drug safety, regulatory affairs, and post-market monitoring. Strong emphasis on utilization of cross-functional skills to advance medical systems and develop process improvements. Results-driven collaborator with effective oral and written communication and presentation skills. Patient advocate and contributor to public health awareness and educa...

Tags for this Online Resume: FDA MedWatch 21 CFR 820 803, Medical Device Class III, ICD, VT / VF, Medical Affairs, Regulatory Affairs, Drug Safety, Quality Assurance and Management, Public Health, Patient Relations, Medical Communication, SAP, Excel

Compliant, but flexible...the best of both worlds

I am primarily interested in obtaining a VP position and using my knowledge to truly direct and enhance a companies experience with quality systems and to provide their customers with products that meet or exceed customer expectations.

Ideal Companies: Medical Device Manufacturers

Tags for this Online Resume: Quality Assurance, Project Management, Auditor, ISO 13485:2003, 21 CFR 820, QSR, Regulatory, Management, Medical Devices

Quality Control manager

Quality Manager with 17 years of experience within the Pharmaceutical Industry. Extensive experience in laboratory operation, laboratory start-up, laboratory automation, manufacturing compliance, new site start-up, deviation assessment, analytical method development and analytical method validation. Strong knowledge and skilled in securing compliance with regulations such as GMP’s, GLP’s and Quality System (21 CFR 820.180)....

Mechanical Inspector- L-3 Communications 5 yrs- Ca

CMM Inspector, Opg , ISO-9000 and ISO-13485,21 CFR820, Mil-std

Featured Profile

Quality Specialist with Proven Track Record

Dynamic, results-driven Quality Professional with a record of achievement and demonstrated success driving multiple programs all while promoting growth by leading with vision and operating cross-functionally. Solid track record with a tenacious ability to forge strong relationships with external business partners. Accomplished in auditing and monitoring quality requirements to meet company quality standards and regulatory r...