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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

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