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Online Resumes with "13485"
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
Quality Manager - 20 Years of Experience - Near 33069
To secure a position in industry utilizing my technical and managerial skills. CAREER CAPSULE: Progressive experience in manufacturing, embracing Production and Quality Assurance. Skilled at directing all phases of manufacturing from Design, Pattern Making, Production, Quality, & Shipping. ISO Management 9001-2008 & 9001-2015. ISO 13485. Proactively managed large and small staffs in manufacturing operations. VAS AERO SERVIC...
Tags for this Online Resume: Management, Quality, Quality Assurance, Quality Management, Audit, Textiles, ISO, MAS 90, Payroll, Quick Books
System Operator - 14 Years of Experience - Near 92883
Professional Summary: A professional in Document Control with a background in Commercial and Aerospace Manufacturing. Responsible for organizing and handling of numerous documents in an office and Manufacturing environment. Qualifications * * 14 years in Document Control * Micro Office Word, Excel Outlook * SAP, Systems Applications, Production * MRP, Material Requirements Planning * SmarTeam, Engineering /Manufacturing pro...
Tags for this Online Resume: Process Control, Administrative Assistant, Document Control, Electronics, Microsoft, Microsoft Office, Microsoft Outlook, Program Manager, ISO, Audit
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
Environmental, Health & Safety Manager - 12 Years of Experience - Near 17851
Areas of Expertise: * Team Leadership * Project Management * Professional Communications * Complex Problem Solving * Research & Development * Product Management * Process Development * Client Relationship Management * Documentation Management * ISO9001/ISO13485 Quality Standards * Cross Functional Collaboration * Cost Reduction Conductor * Manufacturing Operations * Contractor Management * Sourcing & Procurement * Consultin...
Tags for this Online Resume: Manufacturing, Medical, Management, Project Management, Corrective Actions, Engineering, Quality, Quality Assurance, Root Cause Analysis, Telecommunications, project engineer
Managing Director - 5 Years of Experience - Near 92109
Due my extensive experience in development, manufacturing and commercial release of medical devices (SW/HW solutions) following the FDA/ISO13485 and CE regulations, I'm looking for a role as a Sr.Mgr/Director in Product/Project Mgmt or Operations.
Tags for this Online Resume: Integrate, Forecasting, Business Development, Computer Aided Software Engineering, Networking, Oracle, Ethernet, Forecast, Foundry, Management, management, Product Manager, Program Manager, Project Manager
CAD Engineer - 8 Years of Experience - Near 60634
QUALIFICATIONS * ProE (08/2010) * ISO 13485:2003 * SolidWorks (08/2010) * AS 9100C * AutoCad (08/2010) * Design layout and part number creation * Rapid Prototyping/3D Printing * Researching cost saving measures for new products * Aviation QA Inspector (01/2004) * Implementation of design improvements * ISO 9001:2008 * Rotationally Molded Parts
Tags for this Online Resume: MCAD Solidworks, Product Design, Assembly Line, Support, Punch Press, Autocad, Autodesk AutoCAD, English Language, ISO, ISO 9001
Life Scientist - 20 Years of Experience - Near 30523
QA Manufacturing Compliance Lead Lead QA Validation Remediation - Comprehensive Product and Process gap assessments of HVAC, Utility Maintenance programs, product Scale-up through commercial validation, packaging and manufacturing process failures, and customer complaints for Prescription, OTC & DEA products. Conduct review of CMO validation change control and QC OOS/OOT reports and write annual Product Review for all produ...
Tags for this Online Resume: Training, Project Management, Distribution, Management, Risk Management, CFR Part 11, Design Specification, pharmaceutical, protocol, Leadership, Staff development, cleaning validation, process validation, computerized systems validation, Program Management, QC testing, Chemist, CAPA, NCR, Customer Complaints, Supplier Quality, commissioning, equipment qualification, equipment purchase, Change control, Auditing, Medical Devices class I, II and III, Pharmaceutical development DOE, Pharmaceutical Clinical Scale-up, Mfg./Pkg. Management, ISO13485, Technical Reporting, FDA site QA contact
Quality Engineer
ACCOMPLISHMENTS & ACHIEVEMENTS * Researched and budgeted for a vast array of new soldering tips and equipment, microscopes, and specialized lens accessories, and a CMM in order to significantly improve inspection results. Automated SPC measurement systems that resulted in real-time data collection cost savings of $480,000. * Champion of lean six sigma and continuous improvement techniques within Kaizen culture. Became subje...
Tags for this Online Resume: Audit, Legacy, ISO, Management, Procurement, Quality, Quality Assurance, Quality Management, Test, Compliance
Medical Device, Health Technology
Supplier Quality Management, ISO 13485 and supplier audits
Tags for this Online Resume: Supplier Quality Management, Certified Lean Leader, Certified Quality Engineer, Certified Master Black Belt, Certified Supplier Auditor, Certified Process Validation Expert
Quality Assurance - 15 Years of Experience - Near 92116
If your organization has a strong commitment to quality and has integrity, it would be my pleasure to be considered for employment. I am a creative problem solver with a plethora of diverse skills, talents, and experience.
Tags for this Online Resume: quality, communication, project oriented, multi task, bilingual, Audit, Document Control, Management, Quality Assurance, medical devices, Lead auditor, Manager, compliance, pharmaceutical, sap, gcp, regulatory, validation, GxP
Regulatory Affairs, Quality, and Clinical Evaluation Consultant to Medical Device Industry
PROFESSIONAL PROFILE: A focused, driven, and passionate regulatory affairs and quality/compliance/auditing consultant with hands-on experience in RA and Quality/Compliance/Auditing associated with activities which lead to, and maintain regulatory approval to ISO 13485, FDA 510 (k), EU CE Mark & other international market authorizations of medical device products and conformance/compliance of Quality Management Systems. Regu...
Tags for this Online Resume: Management, Regulatory Affairs, Assessments, Audit, Budgeting, ISO, Microsoft Office, Quality, Quality Assurance, Quality Management, oncology, protocol, 13485, FDA, 483, Warning Letter, Portuguese, Spanish, ANVISA, Lead Auditor, Quality Systems, Quality Audit, Medical Device
