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Online Resumes with "21CFR820"
Quality Assurance Manager
As an expert quality management strategist working in the Automotive and Medical Devices industry and in the following standards and concepts as: ISO 9000, TS 16949, ISO 22000, ISO14001, GMP, FDA 21 CFR 820, JPal, Lean Manufacturing, Six Sigma, Etc… for over almost two decades, I offer my keen business acumen and superior quality management skills attached on my resume to your company with an inclination to meet quality sta...
Tags for this Online Resume: Reynosa, Quality Manager, Quality, Matamoros, Queretaro, Medical Devices
Every service event gives us the opportunity to be great and prosperous,Good customer relationships come from honesty and integrity in the way we do business .
After 26 years of field Service I would like to transition into project management or technical sales. I have extensive medical devices back ground and laboratory sciences.
Ideal Companies: Perkin Elmer, Siemens, Agilent, Phillips medical, Trump, Berchtold, Skytron, Mercedes Benz, Google
Tags for this Online Resume: Management, Test, Project Management, Quality Assurance, TQM (Total Quality Management), Infection control, Siemens, Support, Surgical, Technical Support
Quality Manager
I am a quality/lean professional who has worked in highly regulated environment and know what it takes to have manufacturing and office process compliant to regulations with minimum impact to productivity.
Tags for this Online Resume: ISO 9001:2008, Electro-Mechanical Integration, MINITAB, ISO 13485:2003 , FDA 21CFR820 , Lean Manufacturing
Quality Engineer - 9 Years of Experience - Near 07305
apply my skill set in new product development technical reporting laboratory testing of new products guided by 21CFR.820 QSR QSM cGMP and standards ASTM ISO CE
Tags for this Online Resume: Jersey City, cGMP QSR QSM, 21CFR.820, DMR CAPA, QA Engineering, technical specifications, food production, consulting services
Biomedical Engineer - 7 Years of Experience - Near 84115
Tags for this Online Resume: Medical Device Development, 21 CFR 820, Design Control, Biosensors, Medical Devices, biocompatibility, Design , Coatings
Clinical Quality Assurance - 16 Years of Experience - Near 92069
Top performing resourceful operations professional certified in Quality, Six Sigma, Lean Manufacturing, and Project Management, with extensive experience in Integrated Product Teams (IPT), Design Transfer, Quality and Supply Chain Management including: selection, qualification, implementation, design transfer and manufacturing both nationally and internationally Experienced in Operations quality assurance, supply chain mana...
Tags for this Online Resume: change management, operations, quality, california, director, leadership, strategy, improvement
Quality Manager - 20 Years of Experience - Near 60096
Experienced Quality Compliance Professional with expertise in managing internal and external audit programs, medical device manufacturing and sterilization process. Excellent knowledge of quality systems and FDA regulations including a strong background in ISO 9001, ISO 13485, 21 CFR Part 11, 21 CFR 820 and 510(k) submissions. Experience in statistical process control (SPC) techniques based on ANSI standards. Demonstrate...
Tags for this Online Resume: CAPA, FDA, ISO, Complaints, Auditor
Biomedical Engineer - 20 Years of Experience - Near 94025
Key start-up contributor. Extensive knowledge of medical device development and manufacturing. Experienced with distilling physician interactions into new product ideas, assessing new tech/Market, Feasibility and Prototypes. Tenacious, out of the box thinker. Willingness to pitch in to both critical and mundane projects necessary to the company. Visionary innovator/manager with extensive experience in medical products acro...
Tags for this Online Resume: Product Development, ISO13485 21CFR820, Medical Devices, V, Prototyping, Research , Process Development, Commercial release
Product Complaints Specialist
Seeking a position which will allow me to execute as well as challenge my current skill set resulting in performance growth and advancement. Exceptional verbal/written communication, organizational, leadership, analytical, and interpersonal skills
Ideal Companies: Biomedical, Biotechnology, Healthcare compliance
Tags for this Online Resume: compliance, Regulatory
Operations Manager - 18 Years of Experience - Near 97013
Dynamic, results oriented Medical Device Manufacturing Operations Executive who has demonstrated the ability to lead diverse cross-functional teams to new levels of success in medical device manufacturing. Strong analytical, technical and business qualifications with an impressive track record of more than 16 years of hands-on experience in strategic planning, business unit development, project and product management, and s...
Tags for this Online Resume: FDA, ISO 13485, 21 CFR 820, cGMP, Medical Device, Manufacturing, Operations, Production, Development Activities, Documentation, Medical, Medical Devices, Sourcing, Enterprise Requirements Planning, NCR, SAP, Development Activities, Documentation, Medical, Medical Devices, Sourcing, Enterprise Requirements Planning, NCR, SAP
Engineer
SUMMARY: Proven engineering expert with broad global experience in medical device, drug delivery, automotive, and aerospace engineering. Served roles in R&D, Product Development, Manufacturing, Quality, Validation, & Supplier Quality Engineer. Six Sigma Greenbelt. Broad domestic and global Manufacturing & Quality Engineering experience at locations in: US: Utah, Michigan, Ohio, Indiana, Wisconsin, Minnesota, New York, & Mas...
Tags for this Online Resume: Product Development, Quality, Quality Assurance, Research and Development, Six Sigma Greenbelt, Six Sigma Quality, Aerospace, Automotive, Engineering, Global Experience, DOE, IQ/OQ/PQ, FMEA, GR&R, MSA, ISO 13485, 21 CFR 820, Process Validaiton, CNC Machining, CMM Programmer, FAI, Molding, Extrusion, CAD, Toyota Production Systems, Lean Manufacturing, Medical Device, Clean Room Validation
Quality Engineer - 10 Years of Experience - Near 00782
PROFESSIONAL SUMMARY QUALIFICATIONS ASQ member, CAPA Expert Certified, CQA, Quality Risk Management - FMEA, Introduction and Internal Auditor for ISO 9001. Knowledge in cGMP Regulations and International Standard (ISO) as 21CFR820, ISO 13485, 21CFR210 & 211, ISO 9001 & ISO 14001. OSHA Rules, Quality Assurance & Control, Manufacturing, Production, Warehouse, Pest Control. Computer skills: Trackwise, SAP, Maximo, LIMS, Visio,...
Tags for this Online Resume: Manufacturing, Documentation, Quality Assurance, CAPA, Audit, Complaints, Investigations, Good Manufacturing Practices, Internal audit, Management, Systems