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Online Resumes with "CFR820"



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

Medical Scientist

SUMMARY: * 30 years of experience with diverse range of technical and management experience in the drug, cosmetic and medical device business. * Experienced in leading and managing Six Sigma/Lean process improvement projects. * Use of high level business process mapping to diagnose gaps and find opportunities for process improvement. * Strong background in product formulation and reverse engineering techniques. * Experience...

Tags for this Online Resume: Wound Care, 5S, Kanban, Manufacturing, Medical, Medical Devices, MRP, Pricing, Sourcing, Supply Chain

Quality Manager - 20 Years of Experience - Near 37129

SUMMARY * Conduct medical device, cosmetic and pharmaceutical excipient and APIs, and supplier certification, evaluation and qualification activities, including on-site and desktop assessments of quality systems, product and process controls develop control plans for monitoring supplier corrective actions for quality, performance and delivery, employing standard industry tools (pFMEA, root cause investigation, lifecycle man...

Tags for this Online Resume: Instrumentation, Diagnostics, ISO, ISO 9001, Management, Document Management, Software, Assessments, Engineering

Mechanical Engineer - 19 Years of Experience - Near 45039

SUMMARY * Strong expertise in System Engineering, Mechanical design, FEA & Vibration testing * 19 years of industry experience in product development and project management * Medical device design experience familiar with ISO13485 and FDA 21 CFR 820 Standards * Extensive knowledge of electro-mechanical, fluid mechanics and heat transfer * High-level in multitasking using communication, presentation, and management skills * ...

Tags for this Online Resume: Management, Project Management, System design, Systems Engineer, HVAC, Engineering, MEMS, Research, Instrumentation, Legacy

Quality Assurance Director - 20 Years of Experience - Near 33545

BSI ISO 13485:2003 Lead Auditor (TPECS) Certification - Certificate: 7930649-76913 * Hired and entrusted by B Braun McGaw of Puerto Rico and LeMaitre Vascular to implement a wide-array of corrective actions and systems resulting from 3 FDA warning letters. Subsequently after new systems implementation received 0 FDA 483 observations for a combined period of 12 years. * Built company-wide shared quality visions which complet...

Tags for this Online Resume: Documentation, Quality Assurance, Compliance, Pharmaceutical Industry, Quality, Quality Control, Regulatory Affairs, Medical Devices, Pharmaceuticals, Regulatory Compliance

Scientist - 20 Years of Experience - Near 92620

SUMMARY Medical device management professional (MS, MBA) with leadership experience in Stage Gate Product Development Process (PDP), Class I, II and III devices, Systems Engineering, Design Control, Quality Systems Requirements, clinically relevant strategic roadmap creation, capital equipment, IP portfolio management, market-driven technology development, product development, business development, project management, drug/...

Tags for this Online Resume: Business Development, PET, Therapy, Diversity, ISO, Management, Orthopedics, Product Development, Trauma, Cardiovascular, Medical Device leadership

Featured Profile

Director of Quality & Regulatory- 22 Years of Experience - Near 45142

Summary Twenty-two years in the Medical Device Manufacturing Field, including 16 years of Director level experience in Quality Managements Systems, Regulatory Affairs and Quality Assurance/Quality Control Activities. Knowledge and professional experience in the following areas: Quality, Engineering and Manufacturing Implemented practical oversight of the following: * ISO13485 * ISO9001 * 21CFR820 (FDA) * ISO14971 Risk Manag...

Ideal Companies: A company with suability, growth and development of their employees.

Tags for this Online Resume: Audit, Engineering, Management, Management Review, Manufacturing, Medical, Quality, Quality Assurance, Quality Control, Regulatory Affairs, steel, medical device, medical devices, Quality Director, Director of Quality & Regulatory

Electrical Engineer - 11 Years of Experience - Near 10930

Summary of qualifications Over 30 year's experience, this includes the following: * Instrumentation control system development and implementation. These include Process Control, PLC Programming, Water System, HVAC, Clean Room, Analytical instrumentation, Packaging Equipments, Waste treatment, Sterilizer, Compress Air and Steam Turbine Combined/Cogeration. * Write and execute test scripts Installation Qualification, Operatio...

Tags for this Online Resume: ISO, Instrumentation, Medical, Quality, Quality Assurance, Quality Control, Clean Room, Control Systems, Fabrication, Surgery

Electronics Engineer - 20 Years of Experience - Near 30054

Areas of Expertise: * Design for Serviceability * Design for IEC 60601 EMC COMPLIANCE * Design for IEC 60601 SAFETY Compliance * Design for Manufacturability * TRANSITION OF PROTOTYPE DESIGNS TO MANUFACTURING * Analog, Digital & Power Circuit Design * 21 CFR 820 * PCB DESIGN * Research * Hands-on Prototypes * Cross-Functional Teams * ENGINEERING PERSONNEL MANAGEMENT * ISO 9001 * CLASS II AND III MEDICAL DEVICES

Tags for this Online Resume: Rf, Compliance, EMC, System design, Analog Design, Electronics, Magnetic Resonance Imaging (MRI), Research, Networking, Product Development

Clinical Quality Assurance - 20 Years of Experience - Near 46360

Managed Quality Control / Quality Assurance / Regulatory Affairs departments in different roles for different companies for manufacturing packaging and distribution of drugs and devices. Designed flow processes for improvement of quality of products and quality of documents using proper validation protocols and procedures. Built quality management systems three times upgrading: Customer complaints investigations document co...

Tags for this Online Resume: Quality Assurance, Test, HYGIENE, Management, Publications, Quality, Six Sigma Quality, Packaging, Corrective Actions, Instrument Calibration, protocol, pharmaceutical, preventive maintenance

Quality Assurance Director - 20 Years of Experience - Near 92336

A successful Documentation Control Management professional with over 30 years of experience in the Pharmaceutical and Medical Device industry. Excellent communication and interpersonal skills. Committed to motivating and empowering employees to consistently meet or exceed customer expectations and business needs with the following experiences: Quality Management Systems (QMS) development and implementation (QMS was based on...

Tags for this Online Resume: Documentation, Management, Project Management, Pharmaceutical, documentation control, documentation management, quality systems

Clinical Quality Assurance - 13 Years of Experience - Near 92057

QUALIFICATIONS: Over 13 years of experience in the Pharmaceutical and Medical Device Industry. I have a proven desire to enhance team effort and first time quality concepts, Strong creative research skills, Strong detailed and task oriented skills. Work environment regulated by 21 CFR 820 and ISO 13485:2003 & 9001. Specialized in Quality Assurance, Regulatory Compliance, GMP, Document Control, QSR training, Excel, Power Poi...

Tags for this Online Resume: Compliance, Accounts Receivable, Customer Service, Inventory, ANSI, Ansi (Am Natl Stds Inst), Training, Audit, Document Control, ISO