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Online Resumes with "ISO 14971 2012"



Engineer - 19 Years of Experience - Near 33184

Tags for this Online Resume: Audit, Product Development, Risk Analysis, Software, Software Development, Support, Technical Support, Test, Documentation, Quality, Validation, Verification, Human FActor, CAPA, ISO 14971:2012, GMP, 21CFR Part 11, SPC, Post Launch Risk Assesment

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,

Biomedical Engineer - 14 Years of Experience - Near 92563

Career Summary My current job is Verification & Validation (V&V) Manager for the California High-Speed Rail project. I am responsible for managing the requirements database, V&V status reporting, and requirements traceability for the California Rail Builders. I possess considerable experience with ISO 13485 Quality Management System for medical devices standard and ISO 14971:2012 Medical Device Risk Management. My backgroun...

Tags for this Online Resume: ISO, Acceptance Testing, Account Manager, Integrate, Logistics, Manufacturing, Services, Test, Assessments, Critical Care - Vascular, electronics, Metrology