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Online Resumes with "FDA ISO"
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
Quality Manager
CAREER SUMMARY Ethical, strategic, and transformational leader who engages teams to deliver business results and drive sustainable excellence. Engineering Professional/Lean Six Sigma Black Belt with over 20 years + of experience in Quality, Supplier Quality, Process Engineering, and Kaizen/Lean Manufacturing in Food MFG/HACCP., Good Manufacturing Practices (GMPs), Vertical Pump Application, Global Drive Systems, elevators, ...
Tags for this Online Resume: Process Control, Management, SPC, ISO, Policies and Procedures, Project Management, Project Manager, Quality, Quality Assurance, Quality Management
Quality Assurance Director - 18 Years of Experience - Near 55379
Summary of qualifications Global Quality System and Regulatory Compliance Experience in Regulated Environments (Medical Device/Pharmaceutical/Food/In-Vitro Diagnostics) including implementation of design controls * Global Regulatory and Quality Compliance (creating processes for Field Actions/point of contact for all recalls with the FDA/806 and monthly reporting) * Regulatory partnering with FDA and International Agencies ...
Tags for this Online Resume: Documentation, Infrastructure, Management, Program Management, Budget Preparation, Budgeting, Development Activities, P&L, Product Development, Project Management
Director of Quality
CAREER SUMMARY Ethical, strategic, and transformational leader who engages teams to deliver business results and drive sustainable excellence. Engineering Professional/Lean Six Sigma Black Belt with over 20 years + of experience in Quality, Supplier Quality, Process Engineering, and Kaizen/Lean Manufacturing in Food MFG/HACCP., Good Manufacturing Practices (GMPs), Vertical Pump Application, Global Drive Systems, elevators, ...
Tags for this Online Resume: Process Control, ISO, Management, SPC, Black belt, Layout, Policies and Procedures, Project Management, Project Manager, Quality
Director - 23 Years of Experience - Near 28079
Summary Ambitious Sr. Manager with more than 23 years of management experience in Manufacturing/Distribution/Logistics/Repair & Refurbishment environments. Applies strong analytical and critical thinking skills to solve complex operational problems. Ability to direct complex projects from concept to fully operational status, goal-oriented individual with strong leadership capabilities and a passion to succeed. Ability to st...
Tags for this Online Resume: Distribution, Process Improvements, Logistics, P&L, Configuration Management, Configure, IBM, Management, Services, Telecommunications
Medical Transcriptionist
Areas of Expertise * Leveraging 510 (K) PMA and expertise in US, EU, TGA and Canadian medical device regulations. * Manage Kosher/Halal records for ingredients and resale products prepare kosher/Halal applications and registration for products and manufacturing facility. * Knowledge of U.S. FDA medical device regulations (21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807). * Knowledge of ISO 13485, ISO 14971, ISO 9001 and work...
Tags for this Online Resume: Manufacturing, Regulatory Affairs, Test, Advertising, Due Diligence, ISO, Quality Assurance, Compliance, Quality, Quality Control
Marketing & Branding Specialist. Medical Laser Systems
Awarded Graphic Designer, Press and PrePress Specialist, Media and online marketing specialist, web developer and designer. Robotic Engineer - Computer Science. Medical and Scientific Laser Systems. Art and Marketing Director managing teams of over 15 different professions, including graphic designers, programmers, web and UI developers, sales representatives, printers. Best in: brand design, visual identity, package des...
Ideal Companies: candella, cynosure, deka, lumenis, medical devices, advertising companies, tech companies.
Quality Specialist- 3 Years of Experience
Highly motivated team player with the rights skills in Quality Raw Material Assessment, Inspection, Validation, Documentation, Drug and Medical Device Development, and Data Science. I am a Safety conscious individual with proven records in detecting defects, locate and interpret product quality specifications and requirements. Looking to obtain a Quality Assurance or Quality Control position in Biotech and pharmaceutical co...
Ideal Companies: Biotech Companies., Pharmaceutical Companies.
Tags for this Online Resume: Drafting, Test, Medical Devices, Purchasing, Quality Assurance, ISO 9001, Quality Control, Batch Records Review, Environmental Monitoring, Risk Assessment
