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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...