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Online Resumes with "cfr"
Director
SUMMARY OF QUALIFICATION * Extensive experience in FDA regulatory requirements (GMP, CFR) and ISO standard regarding Medical Device, Pharmaceutical, Skin Care, and Food Industry * Extensive experience Lean Quality Tools (FMEA, Pareto Charts, Fishbone Diagrams, Six Sigma 5S, and SPC to assure efficient process and high product quality product * Extensive experience in managing the Supplier/ Vendor qualification program, Supp...
Tags for this Online Resume: Extensive experience in CAPA, Extensive experience in IQ/OQ/PQ VAlidation, Extensive experience Quality audit, Extensive experience Supplier Qualification, Extensive experience FDA and ISO Regulatory, Extensive experience Process and Quality improvement, Extensive experience Reducing customer complaint, Scheduling, Chemistry, Good Manufacturing Practices
Quality Assurance Specialist - 13 Years of Experience - Near 94506
SUMMARY Proficient in developing and applying Software Quality Assurance techniques and strategies to resolve problems in software and compliance with FDA regulation and ISO guidelines in Agile software development environments. Applied SQA principles and methodologies in Manual and Automated Testing with Real Time instruments. Tested instruments Firmware and Drivers. Created, modified and executed test plan and test cases....
Tags for this Online Resume: Real Time Instruments, Test Case Development, FDA, ISO standards, Visual Studio Test Management, Manual and Automated Test, Agile software development, TFS, TestTrack, C#, Python, Troubleshooting, Medical Devices Firmware, Drivers, 21CFR Part 11, Life Science, Data Analysis
Risk Management - 19 Years of Experience - Near 01845
FAMILIARITY WITH: ISO 1009, ISO 10993, ISO 13485, ISO 14969, ISO 14971, ISO 24971, 21 CFR Part 11, 21 CFR Part 820, IEC 62355-1, and HIPPA.
Tags for this Online Resume: Test, Test Plans, Quality, Unix, C++ Programming Language, C/C++ Programming Languages, Java Programming Language, Management, Quality Assurance, Software
Plant Manager
Career Summary: Demonstrated career of adaptability, knowledge and expertise displaying successful execution for delivering finished product, data, analysis and managerial insight efficiently and profitably. Summary of Qualifications: - Role as Master Scheduler, 7 years. - Senior role of two MRP implementations. Jeeves and Orion. - Planned, directed and implemented execution of aggressive inventory schedule planning. - Crea...
Tags for this Online Resume: Scheduler, Forecasting, Inventory, Inventory Control, Manufacturing, MRP, Planning, Production Schedule, Purchasing, Quality
Business Analyst - 7 Years of Experience - Near 48326
2 years About of experience as a business analyst with overall experience of more than 7 years. Started career as a mainframe developer with Tata Consultancy Services. * Have closely worked with leading US auto OEM in recall management and fleet finance engineering Change Management and Bill of Materials applications * Understand and Canadian recalls and other campaigns along with related regulations like NHTSA 573 577 and ...
Tags for this Online Resume: Business Analyst, Business Requirements, Acceptance Testing, Application Development, Gap Analysis, Documentation, JAD
Training & Development Manager
Areas of Expertise: * Commercial Motor Carrier Safety Standards * Commercial Motor Vehicle Driver Training Standards * Air Brake Systems Operations & maintenance Standards * Commercial Vehicle Driver Selection, Orientation, and Training Standards * State & Federal Motor Carrier Safety Regulations (49 CFR 13 CCR) * Department of Education Instructor Certification & Training Standards * Commercial Vehicle Drivers Hours of Ser...
Tags for this Online Resume: Tax Preparation, OSHA, Training, Transportation, Manageement, Audit, Litigation, Child Care, Compensation, Insurance, Passenger Transportation Specialist
Plant Manager - 7 Years of Experience - Near 11705
Tags for this Online Resume: LEAN, 5S, OEE, 21CFR210&211, ISO9001:2008
Mechanical Engineer - 16 Years of Experience - Near 15220
Professional Summary An Engineering and Management Professional with extensive experience in Product Development and Engineering Consulting. Managerial Competencies * Service Delivery * Project management * Customer management * Onboarding new team * Performance management Technical Competencies Medical Devices/Life Sciences * Design remediation of medical devices * Remediation of Knee implant parts * Reverse engineering * ...
Tags for this Online Resume: Consulting, Medical Devices, Engineering Design, Engineering, Product Development, Documentation, Ansi (Am Natl Stds Inst), FDA
Microbiology Quality Leader
Tags for this Online Resume: CFR Part 11, Inventory, Manufacturing, Monitoring, Microbiology, Quality, Quality Assurance, Quality Control, Research, Business Development
Quality Engineer - 10 Years of Experience - Near 00782
PROFESSIONAL SUMMARY QUALIFICATIONS ASQ member, CAPA Expert Certified, CQA, Quality Risk Management - FMEA, Introduction and Internal Auditor for ISO 9001. Knowledge in cGMP Regulations and International Standard (ISO) as 21CFR820, ISO 13485, 21CFR210 & 211, ISO 9001 & ISO 14001. OSHA Rules, Quality Assurance & Control, Manufacturing, Production, Warehouse, Pest Control. Computer skills: Trackwise, SAP, Maximo, LIMS, Visio,...
Tags for this Online Resume: Manufacturing, Documentation, Quality Assurance, CAPA, Audit, Complaints, Investigations, Good Manufacturing Practices, Internal audit, Management, Systems
In Between - 18 Years of Experience - Near 95236
Qualifications: *Hazardous Waste Designing and implementation of sample and profile tracking system. Creation and Implementation of Hazardous Waste Profiling system for Qualifications Specific and generic hazardous waste, low level waste and mixed waste Profiles in accordance with Department of Transportation, Department of Energy and Environmental Protection Agency regulations to insure safe Handling, transportation and di...
Tags for this Online Resume: Customer Service, HAZWOPER, EHS, Instructor, Project Manager, Compliance, Chemist, RCRA, D.O.T., Data Entry
Administrative Assistant - 20 Years of Experience - Near 63016
Summary Expertise in the evaluation of Systems, Processes and Technologies in accordance with multifaceted government standards followed by recommending cost-effective corrective actions and quality improvements.40-60 hour work week. Leadership skills as an Administrator of Maintenance Programs (17 yrs.), with an ability to manage multiple projects, multi-tasks and operations effectively and in a timely manner. Communicator...
Tags for this Online Resume: Airlines, FAA, Insurance, Quality, Audit, D.O.D., Defense, Coding, Communications, Compliance, Customer Service, Sales, Technical Support (Mechanical)
