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Online Resumes with "iso13485"



Aerospace Engineer

Tags for this Online Resume: Power Electronics, Six Sigma, ISO13485

Quality Manager - 20 Years of Experience - Near 94544

Certified ISO 13485 Auditor, with 23 years experience in the manufacturing industry

Tags for this Online Resume: Certified, QMS, ISO9001, ISO13485, FAD, GMP, Manager

Featured Profile

Quality Assurance and Operations Leader

Enthusiastic strategic leader and team-builder with 20 years of experience in people, process, and operational excellence in global matrix healthcare, quality, and financial organizations leading international teams achieving business outcomes while fulfilling standards and requirements.

Ideal Companies: AmerisourceBergen, Johnson & Johnson, MediSafe, Universal Health, LabCorp, Tenet Healthcare, HCA Holdings, Catamaran, Stericycle

Tags for this Online Resume: Quality, Management System, Process Management, Change Management, Integration, Global, Operational leadership, Risk Management, Siebel, SAP, People Soft, Metrics, Cross functional leadership, Reporting, Project Management, Regulatory Compliance, ISO, FDA

Quality Manager - 20 Years of Experience - Near 27288

I am interested in finding a position in Quality where I can make a difference and put the experience and skills I have aquired in to use. Experience in Medical Device, Drug Testing, Wipes, Sterilization, FDA, EPA, OSHA, CAP, CLIA, customer complaint. Implemented cost efficiency, lean manufacturing, internal auditing, supplier auditing, supplier management programs, ISO9001, ISO13485, CAP, CLIA, NCR, MSDS and COA on line s...

Tags for this Online Resume: ASQ, Ethical, Creative, Dedicated, Accomplished, Hard working

Electrical Engineer - 20 Years of Experience - Near 01701

Skilled engineer with 20+ years of experience in the areas of various fields of electronic systems, analog and digital electronics, instrumentation, testing, prototyping, calibration and diagnostic equipment (oscilloscopes, DMM, signal generators and specialized test apparatus incl. microscopes), DC/DC converters, DC Motor Controllers, switching power supplies, low power RF technology. Creating BOM’s, reading and interpreti...

Tags for this Online Resume: Testing, Troubleshooting, Reliability, Electronics, Test, Hardware/Systems, Microsoft Office, Microsoft PowerPoint, Microsoft Visio, Soldering

Quality Manager - 20 Years of Experience - Near 27893

Tags for this Online Resume: 6sigma, Apqp, Internal Auditor, CAPA, ISO 9001, FDA, ISO 13485, SAFETY

Featured Profile

Engineer - 20 Years of Experience - Near 84660

I am a dedicated, reliable, experienced quality professional. I have thrived in a variety of roles such as quality engineer, quality management, regulatory affairs, Technical Writer, Internal/External/3rd party audits as well as MRB Chairman, supplier audits/control, Receiving Inspection and machine shop roles. My passion is to make a differance. Using my experience to document or enhanse quality management systems is m...

Tags for this Online Resume: Salt Lake County, Utah County, Quality Engineer, Quality Manager, Technical Writer, Medical Device, Supplier Engineer, Certified Auditor, CTQ Measure and Resolve, Management Review, Natural Leader, ISO 13485, ISO 9001, 21 CFR Section 820, 21 CFR Section 211, Machine Shop, QA Inspection Manager

Executive Director - 20 Years of Experience - Near 64068

A leader that can initiate and lead change to ensure processes are efficient and facilities maintain competitive advantage. Comfortable performing at all levels, with very diverse groups and multiple facilities. A working technical knowledge of a wide variety of manufacturing processes.

Tags for this Online Resume: SQF Level 3 Practioner, HACCP, ISO 9001, ISO 13485, AIB certifications, Advanced HACCP, BRC certified, Food Defense Coordinator

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 Designer - 20 Years of Experience - Near 14472

Mechanical Designer and Design Engineer with two decades of product engineering and development experience in medical devices. Skilled at leveraging expertise in product prototyping, technical documentation, production oversight, supply chain and quality management. Masterful at applying SOLIDWORKS 3D CAD tools to the development of innovative products. Industry-transferable skills. A best fit for the right OEM company comm...

Tags for this Online Resume: solidworks designer, mechanical designer, Rochester, NY, technical writer, ISO 13485, Quality Assurance

Life Scientist - 20 Years of Experience - Near 55343

EXPERIENCED QUALITY CONTROL AND PRODUCTION SCIENTIST Scientist with over 20 years of experience in manufacturing roles in biotech industry. Relocating to Minneapolis, MN. Strong commitment to quality, producing and testing non-GMP products to fulfill catalog and custom orders in a timely manner. Extensive background in analyzing products to meet product specifications within ISO13485 Quality System. Drives Quality System la...

Tags for this Online Resume: Production Scientist, Material Planner, Quality Control, SAP, EtQ, MRP, Antibodies, Biotech