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Online Resumes with "CFR820"
Operations Manager
Qualifications Profile Lean Green Belt certified professional with career-long expertise in manufacturing operations encompassing quality assurance, project and program management, budget control and allocation, new product development, and strategic planning. Drive operational productivity by integrating Lean principles and leading top-performing teams. Demonstrate adeptness at mentoring and motivating staff and personnel ...
Tags for this Online Resume: Manufacturing, Corrective Actions, Distribution, Electrophoresis, Engineering, Forecasting, Green Belt, Integrate, Inventory, Leadership
Principal Engineer
ACCOMPLISHMENTS * Project management of Medical Device right from conceptualisation to manufacture in an ISO/FDA regulated environment. Used suitable stage gates and milestone list to inform key stakeholders about progress of the project. * Planned the project budget, schedule and used change control procedures for controlling changes and preventing scope creep. Negotiated with functional managers for resource allocation an...
Tags for this Online Resume: Medical, Medical Devices, Engineering, Instrumentation, ISO, Management, Cancer, Documentation, Manufacturing, NPI
Medical Transcriptionist
Areas of Expertise * Leveraging 510 (K) PMA and expertise in US, EU, TGA and Canadian medical device regulations. * Manage Kosher/Halal records for ingredients and resale products prepare kosher/Halal applications and registration for products and manufacturing facility. * Knowledge of U.S. FDA medical device regulations (21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807). * Knowledge of ISO 13485, ISO 14971, ISO 9001 and work...
Tags for this Online Resume: Manufacturing, Regulatory Affairs, Test, Advertising, Due Diligence, ISO, Quality Assurance, Compliance, Quality, Quality Control
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
SENIOR PERSONAL CARE PRODUCTS CHEMIST WITH 15 YEARS OF EXPERIENCE IN FORMULATION, TESTING, AND REGULATORY STANDARDS
Applying my Education and Experience in Every Possible Way to achieve the Maximum Profitability and lowest Cost Possible to the Employer
Ideal Companies: Johnson and Johnson, Proctor and Gamble, Unilever, Colgate - Palmolive
Tags for this Online Resume: ANSI, Ansi (Am Natl Stds Inst), OTC, Quality, Chemist, Formula, Personal Care, Cosmetics, Household, QC, R & D, FDA, Consult
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
Manufacturing and Operations Leader
Highly adept business leader with a strong track record of successful change management in manufacturing and engineering based organizations. Demonstrated ability to excel in management roles with progressive responsibility. Robust background in all areas of Operations management with over 20 years of experience focused on NPI, Lean deployment, site transfers, cost reductions, and QMS compliance. Energetic, people-oriented...
Ideal Companies: Medical Device manufactures
Tags for this Online Resume: Change Management, Coaching, Engineering, Kaizen, Leadership, Management, Manufacturing, Manufacturing Engineering, Medical Devices, Inventory Management, Business Process Improvement, Lean, Continuous Improvement, Quality System, Supply Chain, Warehousing, Process Management, Budget Management, Organizational Develpment, Servant Leadership, Cost Savings, Capital Acquisitions, Plant Leader
Clinical Regulatory Affairs - 20 Years of Experience - Near 80023
SUMMARY OF PROFESSIONAL EXPERIENCE Regulatory, Quality, Clinical and Compliance Medical Executive with major milestones/achievements in the Life Science Industry. Over 30 years in Class III and Class II devices/allograft/biologics, inside/outside the United States (OUS) primarily in the fields of cardiology, cardiovascular, neurology, spine and orthopedics. Integral involvement with 80+ product categories. Personally prepar...
Tags for this Online Resume: Medical Device, Regulatory/Quality, Clinical, Audit, Distribution, Budgeting, Microsoft Windows CE, Advertising, Cardiovascular, Compliance, clinical, trial, protocol, ich, FIM, EFS, gcp
