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Quality Assurance Engineer - QSR/ISO13485 - Validation

To work for a Medical Device company where my experience and skills in Quality Assurance and Validation can be put to good use. What I value most in my career: 1) Personal confidence that I can do the job/task. 2) Upper management confidence that I can do the job/task. 3) Satisfaction that the career/job I’m doing is worthwhile and benefits others. 4) People important in my life recognize value in what I do and that I ...

Ideal Companies: Roche, Johnson&Johnson, Genentech, Eli Lilly

Tags for this Online Resume: Quality Assurance, Medical Device, Validation, ISO 13485 Auditor, TrackWise, Validation - Process, Equipment, ISO 13485 Compliance Auditor, Risk Management, ISO, ISO 9001

Principal Quality Engineer, CAPA, New Product Development

Searching a position as senior/principal quality, manufacturing, R&D engineer focused in mitigation, remediation, redesign and process change for cost savings and product quality enhancement, CAPA initiation and execution, and new product development.

Ideal Companies: medical or Aerospace industries

Tags for this Online Resume: Manufacturing, Medical Devices, Product Development, Research and Development, R&D, IQ/OQ/PQ, Pfmea, Dfmea, Certified Quality Auditor, Six Sigma/ Lean Sigma Green Belt, Quality Foundation Deployment Green Belt, MiniTab, Managing Cross Functional Teams, Solid Works Design, Conceptual Design, New Product Development, Risk Analysis, Negotiations, Customer Relations, Value Engineering, Decrease Field Failure, Increase Customer Satisfaction, Report writing, Authoring and enhancing Standard Operating Procedure, ISO 13485, ISO 14971, ISO 60601-1, Authoring Quality Manual, Design Validation, Verification, Valves, Switches, Linkages and mechanism design and development, Complaint Handling

Specialist at Quality Assurance Management Systems ISO -9001:2015, ISO-13485, ISO-14000 And AAR specs.

Continuing my Career as a Quality Assurance Specialist.

Ideal Companies: GE, Electric Boat, Andon

Tags for this Online Resume: ISO, Quality, Quality Assurance, Quality Control, Statistical Analysis, Lean Manufacturing, Manufacturing, Test, Satellite, Aerospace

Clinical Quality Assurance - 13 Years of Experience - Near 53144

SUMMARY of QUALIFICATIONS Results driven Regulatory and Quality Assurance Management Professional with 12 years Medical Device and Pharmaceutical industry experience. Proven expertise in Quality Systems, Regulatory Compliance, Supplier Quality, Product Manufacturing, Design Control, and Data Systems. Natural leader that enjoys Continuous Improvement and fostering a culture of teamwork by empowering staff to achieve collecti...

Ideal Companies: FK

Tags for this Online Resume: Compliance, Product Development, Quality Assurance, Manufacturing, Audit, Instrumentation, ISO, Management, Medical, Pharmaceutical, device, fda, Regulatory

Quality Manager

SUMMARY 40 years of experience in Quality Assurance/Quality Control, with 30+ years in Quality Management. Working knowledge and ability in multiple environments: Class (7) 10,000 and Class (8) 100,000 Clean Room Construction, Operation, and Control. Medical Component and Device Manufacturing with Test and Assembly, Aerospace Supplier Development, Including all aspects of AS9100 requirements and AS9102 documentation. Multi-...

Tags for this Online Resume: Management, Medical, Aerospace, Automotive, Electronics, Packaging, Quality Assurance, Test, Clean Room, CNC

Biochemist - 20 Years of Experience - Near 19425

My career interest is to work with a science company that strives t to excel and grow there footprint to benefit the everyday life of people. I am an experienced scientist with expertise in quality control, analytical chemistry and biotechnology methodologies in R&D and manufacturing environments. I am highly skilled at method development and problem solving of non-routine assignments. I have a proven ability to successf...

Ideal Companies: Merck, Thermofisher, DuPont, GSK, incyte, any place were science is thriving.

Tags for this Online Resume: Product Development, Electrophoresis, High Performance Liquid Chromatography (HPLC), Analytical Chemistry, Biotechnology, Chemistry, Diagnostics, Green Belt, Leadership, Management, Quality Control, Method development

Supply Chain Manager - 0 Years of Experience

Accomplishments across the Tenure ~ Efficiently revamped 5S LEAN and effectively led operations through ISO 13485 certification process ~ Proficiently minimized temporary workforce by 80%, enhance picking accuracy by 50%+, and develop delivery time by 12% even with the addition of 10-20 daily stops ~ Successfully secured 0 OSHA recordable accidents through the reduction of safety incidents by 31% ~ Planned, designed and imp...

Tags for this Online Resume: Distribution, Filing, Green Belt, Pharmaceutical Industry, Retail, Training, Quality, Quality Assurance, Inventory, Management

Engineering Manager - 31 Years of Experience - Near 85224

Engineering project manager with 25 years' experience designing and manufacturing medical devices and 6 years' experience in business ownership and sales. Driver of all aspects of projects from gathering customer requirements to production release. Specialist with Class II and III combination products. FDA-recognized expert with Design Controls. Highly skilled people and situation manager. Leader at coordinating all depart...

Ideal Companies: Medical Device Companies, Employees 0f 100-250

Tags for this Online Resume: Microsoft Windows, Design Controls Expert, Engineering Project Manager, CAPA Investigator, Technical Sales, ISO 13485, ISO 14971, Internal and Vendor Auditor, FMEA, 510(k), Patents