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Online Resumes with "iso13485"
Design Assurance, Regulatory Compliance - medical device
Tags for this Online Resume: ISO 13485, ISO 14971, ISO 9001, Engineering , MDD Harmonized Standards, CE Marking
Department Manager - 20 Years of Experience - Near 02356
QUALIFICATIONS SUMMARY Extensive experience in Research and Development, Manufacturing Engineering, Test Engineering, Technical Operations and Quality developing, introducing new products and supporting Electro-Mechanical devices. Experienced in working with all facets of the business, internal and external, to increase throughput, quality and product reliability while minimizing cost. Experiences include new product intro...
Tags for this Online Resume: Engineering , Manufacturing, Test, NPI, Concurrent, FDA, Medical, Quality
Quality Assurance Director - 20 Years of Experience - Near 94546
Seeking a Senior level position in Quality to enhance my 20 years of experience
Tags for this Online Resume: Experienced, Manager, Efficient, FDA, ISO 13485, Qualilty System, Materials Manager, Inspector
Biomedical Engineer - 20 Years of Experience - Near 94025
Key start-up contributor. Extensive knowledge of medical device development and manufacturing. Experienced with distilling physician interactions into new product ideas, assessing new tech/Market, Feasibility and Prototypes. Tenacious, out of the box thinker. Willingness to pitch in to both critical and mundane projects necessary to the company. Visionary innovator/manager with extensive experience in medical products acro...
Tags for this Online Resume: Product Development, ISO13485 21CFR820, Medical Devices, V, Prototyping, Research , Process Development, Commercial release
Product Complaints Specialist
Seeking a position which will allow me to execute as well as challenge my current skill set resulting in performance growth and advancement. Exceptional verbal/written communication, organizational, leadership, analytical, and interpersonal skills
Ideal Companies: Biomedical, Biotechnology, Healthcare compliance
Tags for this Online Resume: compliance, Regulatory
Dynamic Project Engineer with 13 years of Mechanical Design experience - BS in Business - Near 54703
Dynamic Project Engineer with 13 years of Mechanical Design experience in fabrication, casting and machining. Demonstrated expertise in customer relations and vendor management. Proven experience in industries including sports medicine, fueling, wire and cable, automotive and fabrication with small companies to Fortune 200 corporations. Skilled at developing electronic communication networks for increased communications and...
Ideal Companies: lockheed martin, Boeing
Tags for this Online Resume: Fabrication , Planning, Product development , Process improvement , Supervision , Mentoring, Analysis , Eau Claire, SolidWorks, Pro-Engineer, Customer relations, Project Management
Operations Manager - 18 Years of Experience - Near 97013
Dynamic, results oriented Medical Device Manufacturing Operations Executive who has demonstrated the ability to lead diverse cross-functional teams to new levels of success in medical device manufacturing. Strong analytical, technical and business qualifications with an impressive track record of more than 16 years of hands-on experience in strategic planning, business unit development, project and product management, and s...
Tags for this Online Resume: FDA, ISO 13485, 21 CFR 820, cGMP, Medical Device, Manufacturing, Operations, Production, Development Activities, Documentation, Medical, Medical Devices, Sourcing, Enterprise Requirements Planning, NCR, SAP, Development Activities, Documentation, Medical, Medical Devices, Sourcing, Enterprise Requirements Planning, NCR, SAP
Quality Manager - 16 Years of Experience - Near 98012
ACCOMPLISHMENTS Lead teams to achieve fastest clearance times for the Ultrasound business unit outpacing all other Medical Device business units in Philips Regulatory Affairs Professional Society (RAPS) Regulatory Affairs Certified (RAC) American Society for Quality Certified Biomedical Auditor (CBA) ISO 13485:2003, ISO 9001:2000, and ISO 14001:2004 Lead Auditor Certified Implemented Japanese Ministerial Ordinance No.169. A...
Tags for this Online Resume: Quality System, Regulatory Affairs, Compliance, Clinicals, ASQ Biomedical Auditor, RAC, ISO13485, Risk
Director - 10 Years of Experience - Near 98036
Summary Management professional with record of setting and executing strategies that drive business results in situations of growth as well as shrinkage. Experience working in high reliability, highly regulated industry, including managing sites certified in AS9100, Mil-Prf 38534, and ISO 13485. Proven ability to manage multiple sites, domestic and international, with a strong focus on development, mentoring, and leadership...
Tags for this Online Resume: Manufacturing, Reliability, Aerospace, Engineering, Manufacturing Engineering, MicroElectronics, Product Development, Supply Chain
Senior Mechanical | Systems Engineer - 20 Years of Experience
Engineering leader in medical device field. Electro-mechanical and systems device developer with numerous patents, and extensive experience in all phases of the new product development process from initial conception through product launch, as well as sustaining engineering. Effective cross-functional team leader and collaborator.
Tags for this Online Resume: Dialysis, Medical Device, Integrate, ISO 13485, Manufacturing, Automation, Functional Testing, Product Development
Senior Quality Assurance Specialist
Summary of Qualifications Dedicated and solutions oriented professional with 14 years of medical device background mainly in Quality & Compliance * Highly motivated with demonstrated ability to set appropriate and effective priorities and implement decisions to achieve both immediate and long-term goals while managing multiple tasks and completing priorities. * Effective communication and inter-personal skills with all leve...
Tags for this Online Resume: Quality, Quality Assurance, Corporate Audit, Manufacturing, Raleigh RTP, Compliance, Internal audit, Supply Chain, FDA
Quality Engineer - 19 Years of Experience - Near 77459
SUMMARY Highly motivated, goal oriented, and efficient Quality Assurance professional with expertise in regulatory compliance, documentation, auditing, and process improvements. Known for ability to complete multi-faced tasks within strict time constraints. Demonstrated expertise in setting priorities and establishing appropriate detailed documentation to meet deadlines using strong clinical, analytical, and technical skill...
Tags for this Online Resume: Quality, Quality Assurance, Quality Control, Audit, Complaints, ISO, ISO 9001, Management, Protocol, Manufacturing, ISO 13485
