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Online Resumes with "CMDR"
Quality Assurance Professional, Tampa
Motivated, personable business professional with 10 years of experience in Quality within the medical device industry. Accustomed to handling compliance and quality support for FDA, ISO13485, MDD, CMDR and JPAL products. Accomplished in Quality System Regulation implementation and improvement activities, auditing, CAPA investigations, root cause analysis, customer complaints, validations and process improvements. Demonstrat...
Tags for this Online Resume: quality, engineer, quality assurance, biology
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Biostatatician
SUMMARY Accomplished and result-driven Quality and Regulatory Affairs professional with 15 years of experience in the Medical device and Drug industry, along with over 17 years of leadership, project management and process improvement (Six Sigma or lean manufacturing). ACCOMPLISHMENTS * Developed, implemented and managed quality systems in GMP and GCP settings based on FDA, ISO, MDD, CMDR, ICH, and IEC regulations and guida...
Tags for this Online Resume:
Training, Cardiovascular, CT, Documentation, Imaging, Magnetic Resonance Imaging (MRI), Management, Medical
Resort Manager - 8 Years of Experience - Near 22152
Additional Qualifications Bilingual Fluent in Spanish & English (primary) Bilingual U.S. Army Reserve, 1995 - 2001 U-31 Combat Signal Support Specialist (Communications) United Parcel Service Training Facilitator NJROTC Battalion CMDR
Tags for this Online Resume:
Adobe, Bilingual, English Language, Facilitator, Graphic Design, HP, Management, Marketing Management, Microsoft Office, Microsoft Windows
Plant Manager - 15 Years of Experience - Near 72000
Career Summary A challenging position and active involvement in a progressive organization offering the opportunity to fully utilize proven and developing skills. Summary of supportive Qualifications * 15 years of experience in Quality Assurance/Quality Control/Quality System * Excellent skills in Quality processes, Design Concepts (Risk Management) and Problem Solving. * Regulatory compliance (FDA QSR, CMDR, IS013485, MDD....
Tags for this Online Resume:
Quality Assurance, Audit, Medical, Compliance, DFMEA, Documentation, manufacturing, ISO13485, Plant Management, Test, Quality Assurance Medical Device
Director of Quality - 20 Years of Experience - Near 91325
Summary of Career Milestones: * BS degree in Industrial Technology. Final semester of a combined Masters Program * 25 years in various manufacturing environments including electro-mechanical, medical devices and Aerospace/Defense * Lean Six Sigma Master Black Belt Certified (LSSMBB) (Global Cert - Germany and Villanova University) * Multiple Quality related certifications from ASQ, ASNT, RAB, IRCA, SME. * Certified Internat...
Tags for this Online Resume:
Test, Engineering, Reliability, Management, Manufacturing
Featured Profile
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
Electrical Engineer - 11 Years of Experience - Near 10930
Summary of qualifications Over 30 year's experience, this includes the following: * Instrumentation control system development and implementation. These include Process Control, PLC Programming, Water System, HVAC, Clean Room, Analytical instrumentation, Packaging Equipments, Waste treatment, Sterilizer, Compress Air and Steam Turbine Combined/Cogeration. * Write and execute test scripts Installation Qualification, Operatio...
Tags for this Online Resume:
ISO, Instrumentation, Medical, Quality, Quality Assurance, Quality Control, Clean Room, Control Systems, Fabrication, Surgery
Quality Assurance Specialist - 20 Years of Experience
Qualification Summary * Strong and diverse professional experience in Quality field Quality Engineering, Supervision, Process Engineering, and Project Management. * Expertise in the application of Statistical Analysis, Advanced Quality Tools, Statistical Process Control (SPC), * Total Quality Management Continuous Improvement. * Excellent Team management/Facilitation skills, handle multiple tasks and fast paced environment....
Tags for this Online Resume:
Data Analysis, Medical, Complaints, Quality, Risk Analysis
Industrial Engineer - 15 Years of Experience - Near 06422
SUMMARY An analytical, results-driven quality management professional with extensive experience leading quality in Medical Devices, Biologics, Combination products, Pharmaceuticals, 510K and 503B Human drug compounding. Hands-on experience in new product development, design for six sigma, validations (IQ, OQ and PQ), risk management, complaints/post market surveillance, CAPA, auditing, supplier management, cGMP/GLP, as well...
Tags for this Online Resume:
Quality Assurance, R&R Report Writer, Test, Quality, Assessments, Complaints, Troubleshooting, ISO, Medical, Medical Devices, Quality ASssurance, Medical Device, ISO, 503B, Complaints, Design Control, Quality,
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