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Online Resumes with "CFR820"



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...

Featured Profile

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...