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Online Resumes with "ISO 13485 2003"
QUALITY ENGINEER has saved $19,570,000
Looking for a company that recognizes the value of continuous improvement I have used the Six Sigma DMAIC methodology to eliminate non-value added activities. Visit customers to share process knowledge and answer technical questions. Work with suppliers to identify defect root cause and verify corrective actions are effective. Qualify new suppliers. Industries: Plastics, Chemical, Automotive
Ideal Companies: Chemical, Plastics, Companies involved in Six Sigma
Tags for this Online Resume: Supervision, SPC, Design of Experiments (DoE), Value Stream Mapping, Continuous Improvement, Six Sigma, Kaizen, Poke Yoke, Suppler Quality Engineer, SQE, Internal Auditor, AutoCAD, ISO 9001:2000, ISO/TS 16949:2002, ISO 13485:2003 Medical Devices, Quality Engineer, Minitab, APQP, PPAP, FMEA, Control Plans, Preventive Maintenance, CMM
Quality Assurance Specialist greater Boston area
Extensive experience in Designing, Implementing and monitoring Quality Management Systems such as ISO 9000:2000, ISO 13485:2003, and 21 CFR 820.Additionally, Supervisory experience in the manufacturing and shipment of medical devices within a multi-culture, fast pace, environment. Coordinated, planned and executed activities to assist manufacturing in meeting production schedules and staying within budget. Good understandi...
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
Compliant, but flexible...the best of both worlds
I am primarily interested in obtaining a VP position and using my knowledge to truly direct and enhance a companies experience with quality systems and to provide their customers with products that meet or exceed customer expectations.
Ideal Companies: Medical Device Manufacturers
Tags for this Online Resume: Quality Assurance, Project Management, Auditor, ISO 13485:2003, 21 CFR 820, QSR, Regulatory, Management, Medical Devices
Validation Consultant/Quality Engineer/QA Mgmt - Biopharmaceuticals/Medical Devices
Seeking Validation/QE/QA Mgmt positions in the Wilson/Raleigh/Greenville NC area.
Ideal Companies: Purdue Pharma, Becton Dickinson, Sandoz, Merck, GSK, Novo Nordisk, Grifols, DSM
Tags for this Online Resume: Validation, QA, SQ, Regulatory, QE, CAPA
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
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, ...
Quality Manager
I am a quality/lean professional who has worked in highly regulated environment and know what it takes to have manufacturing and office process compliant to regulations with minimum impact to productivity.
Tags for this Online Resume: ISO 9001:2008, Electro-Mechanical Integration, MINITAB, ISO 13485:2003 , FDA 21CFR820 , Lean Manufacturing
Chemist - 20 Years of Experience - Near 33411
I am a Quality Assurance professional with over thirty years of experience in Quality Assurance in the Pharmaceutical, Biotechnology and Medical Device Industry.
Ideal Companies: Medical Device or Pharmaceutical Companies
Tags for this Online Resume: Failure Investigation, Corrective Action, Preventive Action, Training, cGMP's, Florida, Auditing, pharmaceutical
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
Medical Scientist
SUMMARY: * 30 years of experience with diverse range of technical and management experience in the drug, cosmetic and medical device business. * Experienced in leading and managing Six Sigma/Lean process improvement projects. * Use of high level business process mapping to diagnose gaps and find opportunities for process improvement. * Strong background in product formulation and reverse engineering techniques. * Experience...
Tags for this Online Resume: Wound Care, 5S, Kanban, Manufacturing, Medical, Medical Devices, MRP, Pricing, Sourcing, Supply Chain
Plant Manager - 10 Years of Experience - Near 60564
Qualifications Profile Results-driven and goal-oriented professional with broad-based experience in industrial engineering, employee relations, quality and operations, product development, and project management. Skilled at establishing and managing contract manufacturers around the globe, while leading its development and ensuring organizational success. Equipped with exceptional ability to build and cultivate professional...
Tags for this Online Resume: Audit, ISO, Manufacturing, Quality, Quality Assurance, Data Analysis, Internal audit, ISO 9001, Process Improvements, Product Development
