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Online Resumes with "510K"
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
Quality Assurance Director - 17 Years of Experience - Near 03062
SUMMARY A resourceful, determined and results driven global quality assurance & regulatory affairs leader with 17 years of experience in R&D, internal & contract manufacturing operation (CMO), supporting domestic & international markets.
Tags for this Online Resume: Product Development, Engineering, Management, Manufacturing, Reviews, Risk Management, Kaizen, Regulatory Affairs, Automation, Compliance, compliance, ASQ, ISO 13485, Design Control, CAPA, Quality Management System, 510k
CEO of Quality/Regulatory Affairs- 19 Years of Experience - New York
SUMMARY Senior Executive with combined technical, regulatory strategy, project management and business experience to build businesses and relationships to deliver new products to market. Over 20 years of experience in medical device, pharmaceutical, biologics, and diagnostic development, including In-Vitro Diagnostic, with market leaders such as Johnson & Johnson, Watson Pharmaceuticals and Mela Sciences. Led worldwide regu...
Tags for this Online Resume: Management, Manufacturing, Product Development, Risk Management, Process Engineering, Engineering, Quality, Quality Assurance, Quality Control, Regulatory, Strategy, Clinical Development, Pharmaceutical, Medical Device, Green Belt, PnL
Quality Assurance Specialist - 7 Years of Experience - Near 55446
SUMMARY: * Around 7 years of experience in Software Testing in Web based Application, Insurance, Healthcare and Banking Applications. * Proficiency in defining, formatting and executing Test Cases based on Business Requirements Ensuring the Traceability for the requirements throughout the testing process. * Good knowledge with Medial Devices (such as ISO13485 standards, IEC60601, FDA processes such as PMA, 510k, Validation ...
Tags for this Online Resume: Java Programming Language, Test, Test Cases, Microsoft Windows, Structured Query Language, Management, Regression Testing, Test Plans, Acceptance Testing, Agile, sql
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
Engineer - 20 Years of Experience
SUMMARY: Hands-on, Multidisciplinary Design Engineer with Project Management and NPI/NPD experience. Electrical, Mechanical, Electromechanical, Controls, Process, and Lean Manufacturing Systems Design, Development, Commissioning and Optimization. * Purpose Built Machinery Design, Development, and Automation for Manufacturing, Assembly, Packaging and Test. Design Specification to Installation and Commissioning, IQ/OQ/PQ (Pro...
Tags for this Online Resume: Electronics, Control Systems, Manufacturing, NEC, Power Distribution, Reliability, Troubleshooting, UL, IEC 60601, Systems Design
Director of Quality - 20 Years of Experience - Near 91325
Summary of Career Milestones: * BS degree in Industrial Technology. Final semester of a combined Masters Program * 25 years in various manufacturing environments including electro-mechanical, medical devices and Aerospace/Defense * Lean Six Sigma Master Black Belt Certified (LSSMBB) (Global Cert - Germany and Villanova University) * Multiple Quality related certifications from ASQ, ASNT, RAB, IRCA, SME. * Certified Internat...
Tags for this Online Resume: Test, Engineering, Reliability, Management, Manufacturing
Chief Executive Officer - 20 Years of Experience - Near 32968
QUALIFICATIONS * Creating High-Performance Teams * FDA 510k Process * Operating Leadership - Accountable * Multimillion-Dollar Resource Management * Innovator - Creating Breakout Growth Plans * Technology licensing & Acquisition * Capital Sourcing, M & A, Roll-ups, Bolt-On's * Non-Profit Executive Leadership * Executable GTM Sales & Marketing Strategies * Mobilization, Donor Development * Agile Software Development Environm...
Tags for this Online Resume: New Ventures, Investor backed, Business Development, Innovator, Call Center, Equity, Equity and Debt, Management, Manufacturing, Product Development
Health Technologist - 0 Years of Experience - Near 11746
SUMMARY Senior Quality and Regulatory professional experienced in high tech and medical device manufacturing industries. Progressive responsibilities in all areas of Quality Systems in the implementation of TQM, SPC, Six- Sigma, re-engineering, Continuous Improvement, Quality function deployment, implementation of FDA-GMP or QSR, ISO-9001, EN-46001, ISO 13485, EC Directives for CE marking on products, Clinical trial and Pro...
Tags for this Online Resume: Management, Medical, Operating Room, Policies and Procedures, Project Management, Rf, Software, Software Development, Surgical, Test
Chief Operating Officer
Professional Summary: Skilled in Medical Device Field, Mergers & Acquisitions, Start-ups, Healthcare Research, with strong communication (oral and written) skills -, multi-tasking, project-management skills, research writing, fund-raising presentations, plus other outstanding professional qualities. and * Spent over 10,000 hours in developing the company's prototype. * Implemented a pilot study at a Boston hospital for medi...
Tags for this Online Resume: Equity, Medical, Research, Clinical Research, Start-ups, Hedge Fund, Securities, Series 7, Investment Opportunities, Acquisitions, outside sales, business development, marketing, account executive, technical sales, management, sales
Project Manager - 20 Years of Experience - Near 91302
SUMMARY OF QUALIFICATIONS Accomplished IT Sr. Project Manager and Product Manager with a broad background, over 20 years of experience in all phases of SDLC including the areas of Application Development, Implementation, Deployment, Project Management, Process Improvement, Computer System Validation and other positions of increasing technical responsibility. Knowledge of regulatory requirements and cGMP for computer systems...
Tags for this Online Resume: Database, Database Design, Integrate, Business Requirements, Javascript, BASIC Programming Language, FACETS, Hospital Information Systems, HyperText Markup Language, Legacy, Project Management, Agile, Scrum Master
Quality Professional
Qualifications Skills: Regulatory Affairs/quality assurance: Projects, related skills and practice include: * Prepare and submit 510 (k) s for US FDA on Class I and Class II Medical Devices and assisted with the preparation of Class III submittals * Compile, document and submit Technical Files for Europe (CE Marking) per Medical Device Directive (MDD) * Perform monthly trending analysis * Developing quality systems plan inc...
Tags for this Online Resume: Manufacturing, Medical, Medical Devices, Risk Analysis, Documentation, Failure Analysis, ISO, Quality Assurance, Quality, Statistical Analysis
