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Were you looking for 510K-submission job results?
Click Here to search for 510K-submission in our 2.4M jobs.
Online Resumes with "510K submission"
I am known as a volume producer; task orientated, detailed and very organized who readily adapts to rapidly changing priorities.
I am experienced in the fields of Documentation and Change Control Systems, Design Controls/Audits and Risk Assessment Analysis / Management, Project Leader, Accounting, and Data Processing.
Ideal Companies: Stable
Tags for this Online Resume: Regulatory Specialist EU, Document Control Manager
Goal focused Quality Leader in medical devices and pharmaceuticals
Began career with 10 years with the FDA in the Detroit District office and at the Kalamazoo, MI and Grand Rapids Resident Posts. Conducted inspections at pharmaceutical and medical device companies, conducted investigations and testified in court. I Left for a start-up medical device contract manufacturer where I developed the quality system and initiated 510(k) submissions. I also identified and resolved problems result...
Ideal Companies: Small to large medical device or pharmaceutical companies such as Abbott Laboratories, Baxter, CR Bard, Phillips, Medtronic, Boston Scientific, St. Jude Medical, Johnson & Johnson, Bausch and Lomb.
Tags for this Online Resume: Quality Systems Management, Regulatory Compliance, ISO 9001:2000/ISO 13485:2003, Pharmaceutical GMPs
QA Manager, document Control
I have over 30 years of experience in the medical device, pharmaceutical, and biologics experience with a strong background in Class III Medical Device Safety and pharmaceutical quality and compliance. My management background included coordinating inspection assignments, managing investigation activities and assigning investigation tasks to all involved departments, preparing summary reports, reporting metrics for complain...
Product Development Manager
Highly effective educator with excellent communication and organizational skills.
Ideal Companies: Johnson and Johnson, Merck, Medtronic, Wyeth
Tags for this Online Resume: Business Development, Education, Training, Education Director
Experienced Validation/Product Development, Investigation Manager (Medical Devices)
To be an active participant in the validation, product development/launch, product improvement, product investigation, product compliance of a medical device or biotechnology related item.
Ideal Companies: Johnson & Johnson, Pfizer, Roche, Abbott, Battelle, University of Virginia
Tags for this Online Resume: Validation, CAPA investigations, FDA regulated devices, Product Development, FMECA, Manager, Failure Investigations, Data analysis, Plan/Report writing, Process Excellence, Project Management, Policy Development, Procedure Development, Medical Diagnostic Devices
Director of Quality - 15 Years of Experience - Near 77086
10+ years medical device industry in variety of areas including Regulatory strategy for domestic and international marketing. FDA submissions of 510k and EU submissions of Technical Files for CE Mark. Implementation of Quality Systems per QSR, Health Canada, ISO 13485:2012, Medical Device Directive 93/42/EEC and Active Implantable Medical Device Directive 90/285.
Tags for this Online Resume: Quality Systems, Medical Device, Regulatory Affairs, 510K submission, CE Mark, Consultant, Director, Vice President
Quality Manager - 20 Years of Experience - Near 60096
Experienced Quality Compliance Professional with expertise in managing internal and external audit programs, medical device manufacturing and sterilization process. Excellent knowledge of quality systems and FDA regulations including a strong background in ISO 9001, ISO 13485, 21 CFR Part 11, 21 CFR 820 and 510(k) submissions. Experience in statistical process control (SPC) techniques based on ANSI standards. Demonstrate...
Tags for this Online Resume: CAPA, FDA, ISO, Complaints, Auditor
Mechanical Engineer
SUMMARY Results-oriented Engineering Professional, with extensive experience designing and delivering medical, bio-medical, and scientific diagnostic instrumentation to achieve overall business objectives. A clear communicator, that is flexible and adaptable, with the ability to work effectively across organizational lines to deliver projects on schedule. A seasoned engineer and project manager, with the expertise to develo...
Tags for this Online Resume: Drafting, Engineering, Instrumentation, ISO, ISO 9000, Manufacturing, Manufacturing Engineering, Reviews, Support, Surgical
Radiologic Technician - 20 Years of Experience - Near 80234
Seeking a challenging position in the field of MRI where my 26 years of experience will contribute to the success of an Imaging Center. Desire a solid career potential with a progressive organization. A company that promotes patient care and integrity. Professional Highlights Registered in Computer Tomography 2012 Certified in MRI since 1990 Currently operating the GE 3.0T HDx GE 1.5T HDx, GE 16 Slice CT Scanner Advanced Ap...
Tags for this Online Resume: healthcare, MRI Technologist, Magnetic Resonance Imaging (MRI), Diagnostics, Beta Testing, Compaq Alpha, Protocol
Director of Quality - 20 Years of Experience - Near 08053
Seeking a Senior Management Position to achieve business excellence in a progressive company utilizing my proven leadership skills, strategic planning and team building skills.
Tags for this Online Resume: Quality, Docuementation, 510(k) Submissions, Training, Write SOP's & Work Instructions, Health Canada Submissions, 3rd Part Audits, Customer Service, Quality Manuals
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
Project Manager - 15 Years of Experience
Career Highlights Conducted requirements analysis and user feedback sessions (internal users to members of Congress) and provided summary analysis with recommendations for user experience improvements. Produced next generation site with more intuitive user interface. (Canton Group) Managed successful launch of portal for Audi of America (AoA) by leading requirements gathering, prototyping, client feedback, presenting update...
Ideal Companies: Frog Design, Google, uShip
Tags for this Online Resume: Product Development, Test, Test Plans, Management, Medical, Project Management, Protocol, Troubleshooting, Applications, Cascading Style Sheets, agile, software, html, requirements gathering, QA
