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Online Resumes with "13485"



Featured Profile

Project Manager, Systems Engineer, Team Leader

Resourceful professional with wealth of experience as systems engineer in manufacturing, mechanical design, satellite ground systems, data process/network development, and hardware/software integration, working within U.S. Department of Defense (DoD) classified environments. Accomplished lead designer and project manager with impressive portfolio of completed capital and engineering projects, including manufacturing cleanro...

Ideal Companies: Radford Building Solutions, Covidien, Digital Globe, Ball Aerospace, Lockheed Martin, Boeing, McKesson, ULA, NOAA, NREL, Ranger Boats, NDP, CH2MHill

Tags for this Online Resume: Systems Engineering Expertise, Project Design, Project Manager, DoD Top Secret Clearance, Strategic Planning, Process Development, Process Improvement, Needs Assessment, Team Leadership, Data Warehousing, Presentations, Inventory Management, Talent Management, AUTOCAD, DOORS, IT Strategy, Logistics, Outsourcing, Information Technology, Risk Mitigation, Manufacturing, Product Design, Program Management, Engineering Management

Quality Manager - 11 years experience - Medical Device - ISO 9000, ISO13485, GMP, FDA

Continue to help companies maintain or create a constantly improving quality system.

Tags for this Online Resume: Quality Manager, Manage Internal, External and Supplier Audit Program, • Management liaison with all customer, third party and FDA auditors., CAPA / Process Improvement, Process Improvement, Document Control Specialist

Featured Profile

Six-Sigma Black Belt & Quality Lead Auditor Medical Device, Statistical Black Belt Quality

Work Full Time or ontract in either/or fields.

Tags for this Online Resume: Six sigma, Iso 13485, Iso 9001, Asq Certified Black Belt, Iso 9000, ISO Registration Services, Iso 9001 RAB/QSA Lead Assessor

Quality Specialist with Proven Track Record

Dynamic, results-driven Quality Professional with a record of achievement and demonstrated success driving multiple programs all while promoting growth by leading with vision and operating cross-functionally. Solid track record with a tenacious ability to forge strong relationships with external business partners. Accomplished in auditing and monitoring quality requirements to meet company quality standards and regulatory r...

Quality Assurance Director

Dear Hiring Manager, I am a Quality Assurance Executive with solid experience and achievement in Quality Systems Implementation, Organizational Refinement, Global Supplier Development, Lean manufacturing, Cost Reduction, and Preventive Problem Solving; encompassing the Aerospace, Automotive OEM Tier 1, Medical Device, and Consumer Electronics manufacturing industries. I am attaching a copy of my professional resume for you...

Tags for this Online Resume: USA, Director, Medical, Quality, Aerospace, Global

Purchasing Agent - 20 Years of Experience - Near 94560

I am an Experienced Senior Materials Management Professional offering extensive experience in Materials management and Procurement for Medical device and Semi-conductor companies from NPI through production.

Tags for this Online Resume: Senior Buyer/Planner, Bay Area, Experience with ISO 13485, Materials Management, Salary $88,000-$89,000, Ability to mange a high volume of parts with successful out come!, Outsourcing, Audit, Compliance, Distribution, Inventory, Inventory management, Management, NPI

QUALITY SENIOR ENGINEER / QUALITY MANAGER

Corporate or mid-size companies requiring an experimented Quality Profesional with very good knowledge in ISO standards and very good background evaluating & auditing suppliers to validate process and/or DOE.

Tags for this Online Resume: ISOstandards, ISO9001, SAP, QAManager, ISO13485, GD, QMS, PPAP, Auditing

Senior Manufacturing Executive

I am a senior manager in a combination medical device manfuacturing company that aspires to contribute significant bottom line results at a senior level in a market leading consumer products or medical device manufacturing enterprise located in the south eastern US, preferably in the Miami or Atlanta Areas.

Tags for this Online Resume: Relocation, Supply Chain, Manufacturing , Medical Device, CFR21.820, ISO13485

Regulatory Affairs Assistant at Medical Device Company-1 year experience-Boston

*Developed Quality Assurance and Regulatory Affairs processes, and managed databases. *Familiarity with medical device regulations, standards: ISO 13485 and FDA guidances *Support the submittal of product regulatory filings and maintenance with focus on US 510(k), EU technical files. *Review design control documents including protocols and reports associated with design inputs and outputs. *Interested in international m...

Tags for this Online Resume: regulatory, quality, medical device, international regulatory, FDA, 510k

Senior Medical Device Account Manager 10 years experience - 60601 and 13485 certified

I'm dynamic, top-performing professional with significant industry expertise and comprehensive 10-year background in pharmaceutical / medical device sales and marketing. Verifiable record of achievement increasing profitability for companies with global footprint. Consistently successful in penetrating new territories, identifying targets, and capturing new business. Assertive, polished, goal-driven professional committed t...

Tags for this Online Resume: Medical Project Management, Medical Device, Account Manager, 13485, Medical Consulting, Boston, Medical Device Project Management, Medical Device Sales, MedicalDevice Consulting

Process Engineer, Quality Engineer/Engineers, Bay Area, California

To have a challenging position in Process Engineer, Quality Engineer/Engineers, where I could apply all major principles of design and engineering such as implementing manufactures processes, maintaining and improving new products for production line, and transferring designs into manufacturing to ensure that product is manufactured to meet compliant regulatory requirements such as cGMP’s, QCEM, validation, ISO13485:2003, ...