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Online Resumes with "Design Control"
Quality Professional
Qualifications Skills: Regulatory Affairs/quality assurance: Projects, related skills and practice include: * Prepare and submit 510 (k) s for US FDA on Class I and Class II Medical Devices and assisted with the preparation of Class III submittals * Compile, document and submit Technical Files for Europe (CE Marking) per Medical Device Directive (MDD) * Perform monthly trending analysis * Developing quality systems plan inc...
Tags for this Online Resume: Manufacturing, Medical, Medical Devices, Risk Analysis, Documentation, Failure Analysis, ISO, Quality Assurance, Quality, Statistical Analysis
Industrial Engineer - 20 Years of Experience - Near 35243
SUMMARY OF QUALIFICATIONS: Experience with project development in accordance with design controls per Company Quality System Controls. (ISO) Following all requirements in the aspects of design, testing and manufacturing, including regulations for environmental requirements and customer requirements required for bidding the job. Fluent in the use of mechanical modeling and design software using AutoCAD and AutoDesk Inventor ...
Tags for this Online Resume: Manufacturing, Product Development, Quality, Test, Autocad, Autodesk AutoCAD, CIO, Layout, Sales, Structured Query Language
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
Quality Assurance Director - 3 Years of Experience - Near 94566
Walter holds a Master's Degree in Systems Management and a Bachelor's Degree in Industrial Engineering/ Quality Engineering. Walter is a Six Sigma Lean, Black Belt. He has extensive years of experience as Director and Senior Manager positions in Quality and Operations positions for Bio-Tech, Pharmaceutical and Medical Device industries. He has hands on experience in Project Management, Design Control Pre-Market, Post Market...
Tags for this Online Resume: Management, ISO, Compliance, Documentation, Risk Assessment, Audit, Manufacturing, Project Management, Project Manager, Risk Management, Quality Systems Professional
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
Process Engineer - 20 Years of Experience - Near 30076
QUALIFICATIONS SUMMARY A self motivated Professional Engineer (PE) and Project Manager Professional (PMP) with years of industrial experiences in manufacturing, product development, engineering consulting and construction management. Areas of expertise include: * Seventeen (17) years project management experience in global companies * Extensive experience in global technical leadership and consulting service for global comp...
Tags for this Online Resume: ISO, ISO 9000, Engineering, Management, Cost Control, Project Management, Test, APQP, Construction, Product Development, Medical Device R&D, Design Control, Quality Control of Medical device, Quality Management SYstem
Quality Manager - 15 Years of Experience - Near 02780
Quality professional - 15 years experience in quality systems and validations for medical devices, biologics, and combination products.
Tags for this Online Resume: Risk Analysis, Test, Packaging, Protocol, Manufacturing, Documentation, Management, Systems Documentation, Compliance, Quality systems
Accountant - 10 Years of Experience - Near 76014
GAAP Update seminars SAP System Mastering in modules: Finance, Warehouse and Purchase. Navision and AX System -General Leader Quick Books, Accounting, Checks & Financial Information. Microsoft Office Excel, V-lookup, Pivot table, word etc. Compaq System Mastering in Accounting Module Honesty, Passion to work, Openness, Results Oriented, Conflict solver, Communication, ability to work under pressure. Good analytical and or...
Tags for this Online Resume: Audit, Inventory, Management, Reconciliations, SAP, Internal Controls, Accounting, Accounts Receivable, Payroll, Bilingual, accounting, finance, audit, manufacturing, gaap, excel, accountant, controller, cpa
Engineer - 20 Years of Experience - Near 77479
SUMMARY Over thirty years of experience in the design, engineering, commissioning, and operation of oil and gas production facilities and process plants including offshore fixed platforms and floating facilities (FPSO, Spar, Semi-submersible), pump and compressor stations, fiscal metering systems, instrumentation and controls for oil and gas gathering, treatment and processing facilities, refineries and LNG plants. Over thi...
Tags for this Online Resume: Engineering, Floating Production Storage, IDS, Valves, LNG, Compressors, Control Systems, Documentation, Project Coordinator, Refinery
Industrial Engineer - 15 Years of Experience - Near 06422
SUMMARY An analytical, results-driven quality management professional with extensive experience leading quality in Medical Devices, Biologics, Combination products, Pharmaceuticals, 510K and 503B Human drug compounding. Hands-on experience in new product development, design for six sigma, validations (IQ, OQ and PQ), risk management, complaints/post market surveillance, CAPA, auditing, supplier management, cGMP/GLP, as well...
Tags for this Online Resume: Quality Assurance, R&R Report Writer, Test, Quality, Assessments, Complaints, Troubleshooting, ISO, Medical, Medical Devices, Quality ASssurance, Medical Device, ISO, 503B, Complaints, Design Control, Quality,
Electrical Engineer - 20 Years of Experience - Near 48186
Profile: Electrical & Controls Engineer * 15+ years of experience in the design, installing, testing, commissioning and start-up, optimization, and maintenance of electrical equipment in automotive manufacturing environment. * Designed control panels for automotive production lines, program and troubleshoot electronic controls systems including PLC, HMI, motor drives and converters. * Automotive seat design and testing, man...
Tags for this Online Resume: BAR, Coding, Distribution, Security, Security Systems, Switches, Siemens, Test, Automotive, Ethernet
