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Online Resumes with "ISO 14971"
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
Plant Manager - 15 Years of Experience - Near 72000
Career Summary A challenging position and active involvement in a progressive organization offering the opportunity to fully utilize proven and developing skills. Summary of supportive Qualifications * 15 years of experience in Quality Assurance/Quality Control/Quality System * Excellent skills in Quality processes, Design Concepts (Risk Management) and Problem Solving. * Regulatory compliance (FDA QSR, CMDR, IS013485, MDD....
Tags for this Online Resume: Quality Assurance, Audit, Medical, Compliance, DFMEA, Documentation, manufacturing, ISO13485, Plant Management, Test, Quality Assurance Medical Device
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 Engineer
Summary To contribute my Engineering, Management, Client service, Computer Application, Continuous process improvement, quality management, and manufacturing operations expertise to a successful and growing organization. Expertise * Significant expertise with Continuous Improvement and Quality Tools, including Histograms, Pareto, Gantt Charts, and Flow Diagrams * Lean Manufacturing and Kaizen Event experience * Proficiency ...
Tags for this Online Resume: Quality Assurance, Training, 5S, CMM (Capability Maturity Model), Kaizen, R&R Report Writer, Data Analysis, Failure Analysis, Management, Root Cause Analysis
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
Quality Assurance Specialist - 20 Years of Experience
Qualification Summary * Strong and diverse professional experience in Quality field Quality Engineering, Supervision, Process Engineering, and Project Management. * Expertise in the application of Statistical Analysis, Advanced Quality Tools, Statistical Process Control (SPC), * Total Quality Management Continuous Improvement. * Excellent Team management/Facilitation skills, handle multiple tasks and fast paced environment....
Tags for this Online Resume: Data Analysis, Medical, Complaints, Quality, Risk Analysis
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,
Quality Engineer - 13 Years of Experience - Near 92630
I enjoy working with start-up or multi national/ global medical device companies. Apply my experience in mechanical engineering to design & development, remediation projects for class II medical devices.
Tags for this Online Resume: Product Development, Manufacturing, Medical Devices, Product Design, Training, Documentation, Packaging, Test, "project management", production, mechanical engineer, Project Engineer, USFDA 21 CFR (QSR), ISO 13485 (QSR), ISO 14971 (Risk Mngt), MDD/93/42/EEC, QA Engineering, Contract Eng. Start-up & Multi National/Global
Manager
Working at Johnson & Johnson (5 years-current) Allergan (4 years) Breath Technology (1 year) Nobel Biocare (1 year) Transforming customer expectation into clearly defined product requirements Leading cross-functional team to ensure the product vision is implemented correctly and effectively. Experience in defining a product roadmap and leading programs that meet aggressive goals and deadlines Analytical aptitude and data-dr...
Tags for this Online Resume: Assessments, Communication Skills, Competitive Analysis, Consulting, Data Analysis, ISO, ISO 9000, Management, Manufacturing, Market Research, management, manager
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
Quality Coordinator - 5 Years of Experience - Near 08817
PROFESSIONAL PROFILE SUMMARY * A Quality professional with over twenty years' experience in Pharmaceutical and Biotechnology industries. Expertise in pharmaceutical, biological and aseptic manufacturing of sterile injectable and non sterile drug products with an emphasis on regulatory compliance including deviation review (laboratory and production), FDA inspection readiness, quality systems and cGMP compliance. Implemented...
Tags for this Online Resume: Management, Compliance, Reviews, Pharmaceutical, Audit, Documentation, Quality Assurance, Test, Manufacturing, manufacturing, production, reliability, mechanical engineer, electrical engineer, machine operator, maintenance, die cutting
