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Online Resumes with "Design History Files"
I am known as a volume producer; task orientated, detailed and very organized who readily adapts to rapidly changing priorities.
I am experienced in the fields of Documentation and Change Control Systems, Design Controls/Audits and Risk Assessment Analysis / Management, Project Leader, Accounting, and Data Processing.
Ideal Companies: Stable
Tags for this Online Resume: Regulatory Specialist EU, Document Control Manager
Accomplished New Product Development & Quality Assurance Manager
� Accomplished, self-starting New Product Development and Quality Assurance engineering manager � Over 10 years of experience in medical device development � Hands-on experience leading product development cycle from concept selection to commercialization in both New Product Development and Quality Assurance management roles, including voice of customer activities, concept selection, design characterization, verification an...
Ideal Companies: Johnson & Johnson, General Electric, Kimberly Clark
Tags for this Online Resume: Quality, New Product Development, Manager, Medical Device, Biomedical, NPD, Engineer, Research , QA, Development, Quality Assurance
Quality On My Mind
Experienced Quality profession dedicated to designing and implementing profit-centric Quality solutions
Ideal Companies: Alcon Labs, Boeing Inc., ASRC, Bayer
Tags for this Online Resume: Quality, Project Management, Software Validation, Product Validation, Corrective Action, Root Cause Analysis, Auditing, Public Speaking
Biomedical Engineer - 2 Years of Experience - Near 94105
SUMMARY A highly skilled Biomedical engineer familiar with every aspect of medical devices from concept to commercialization. Qualifications include design history file management, SOLIDWORKS associate certified (in progress), 3D printing and prototyping, six-sigma methodology, FMEAs, manufacturing process, FDA submission.
Tags for this Online Resume: Biomedical Industry, Bluetooth, C++ Programming Language, Documentation, Engineering, Management, Manufacturing, Biomedical engineer, Medical devices, Solidworks, Six sigma, FMEAs
Director of Quality & Regulatory- 22 Years of Experience - Near 45142
Summary Twenty-two years in the Medical Device Manufacturing Field, including 16 years of Director level experience in Quality Managements Systems, Regulatory Affairs and Quality Assurance/Quality Control Activities. Knowledge and professional experience in the following areas: Quality, Engineering and Manufacturing Implemented practical oversight of the following: * ISO13485 * ISO9001 * 21CFR820 (FDA) * ISO14971 Risk Manag...
Ideal Companies: A company with suability, growth and development of their employees.
Tags for this Online Resume: Audit, Engineering, Management, Management Review, Manufacturing, Medical, Quality, Quality Assurance, Quality Control, Regulatory Affairs, steel, medical device, medical devices, Quality Director, Director of Quality & Regulatory
