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Online Resumes with "cfr"



Quality Assurance Specialist - 20 Years of Experience - Near 80421

Areas of Expertise FDA ISO / IEC Quality Systems Risk Management FMEA V&V Testing Web Application Testing HLM / Quality Center SDLC Qualification Protocols Agile RoHS Compliance

Tags for this Online Resume: Documentation, 21 CFR Part 11, Quality Center, Quality Assurance, Testing, ISO, Validation, Agile, Audit, Compliance, IEC, JIRA, FDA, Software, IQ, OQ, PQ, Medical, FMEA, Functional, Acceptance, Performance, Verification

Engineer

SUMMARY: Proven engineering expert with broad global experience in medical device, drug delivery, automotive, and aerospace engineering. Served roles in R&D, Product Development, Manufacturing, Quality, Validation, & Supplier Quality Engineer. Six Sigma Greenbelt. Broad domestic and global Manufacturing & Quality Engineering experience at locations in: US: Utah, Michigan, Ohio, Indiana, Wisconsin, Minnesota, New York, & Mas...

Tags for this Online Resume: Product Development, Quality, Quality Assurance, Research and Development, Six Sigma Greenbelt, Six Sigma Quality, Aerospace, Automotive, Engineering, Global Experience, DOE, IQ/OQ/PQ, FMEA, GR&R, MSA, ISO 13485, 21 CFR 820, Process Validaiton, CNC Machining, CMM Programmer, FAI, Molding, Extrusion, CAD, Toyota Production Systems, Lean Manufacturing, Medical Device, Clean Room Validation

Not Listed - 20 Years of Experience - Near 33010

Experience Summary: College Professor, Miami Dade College. Miami, Florida. Aviation Accident Investigator: United States, National Transportation Safety Board domestic and foreign investigations. Aviation: aircraft maintenance, safety, and manager. Mechanic to supervisor. United States Air Force military and civilian (Code of Federal Regulation {CFR}, Title 14, Part 91, 121, 129, 135, and 145) maintenance and aviation safet...

Tags for this Online Resume: Power Plants, Management, Project Management, Project Manager, Airlines, Logistics, Procurement, Utilities, Engineering, Corrective Actions

Supply Chain Manager - 18 Years of Experience - Near 11021

Summary of Qualifications A Logistics Manager, Supply Chain Specialist with 18 years of experience and a proficient track record of increasing operational efficiency and productivity by creating policies and implementing procedures to improve quality and workflow while reducing costs, eliminating waste and promoting change. Possess a strong foundation and understanding in Supply Chain Management, Warehousing, Inventory Anal...

Tags for this Online Resume: Inventory, Sales, Distribution, EDI, Electronic Data Interchange, Logistics, Supply Chain, apparel, Data Migration, Enterprise Requirements Planning

Featured Profile

Nuclear Engineer - 20 Years of Experience - Near 89084

I am interested in immediate placement in a position that suits my knowledge, skills, and experience, and allows for career growth. I am a Senior Nuclear Licensing, Regulatory Affairs, and Compliance Specialist. I also have vast experience in Decommissioning, Project Management, Project Engineering, 10 CFR 50.59 Safety Evaluation, Safety and Design Basis Documentation, Quality Assurance, NRC IP 9500X and IMC 0350 Rec...

Ideal Companies: NEC, Inc.; WD Associates, Enercon, EnergySolutions, AECOM, Bechtel, USA Repository Services, NRSS, NSTec, NNSA, DOE, NRC, Gilbert Services, Hukari, GEM Technologies

Tags for this Online Resume: Compliance, Test, Consulting, Licensing, Regulatory Affairs, Configuration Management, Configure, Management, Cause Analysis, Supervision, Corrective Action, Nuclear, Quality Assurance, Project Management, Program Management, Inspection, Recovery, Analysis, Performance Improvement, Safety Culture, Change Management

Mechanical Engineer

SUMMARY Results-oriented Engineering Professional, with extensive experience designing and delivering medical, bio-medical, and scientific diagnostic instrumentation to achieve overall business objectives. A clear communicator, that is flexible and adaptable, with the ability to work effectively across organizational lines to deliver projects on schedule. A seasoned engineer and project manager, with the expertise to develo...

Tags for this Online Resume: Drafting, Engineering, Instrumentation, ISO, ISO 9000, Manufacturing, Manufacturing Engineering, Reviews, Support, Surgical

Quality Assurance Director - 13 Years of Experience - Near 60453

SUMMARY * 17 years of experience in pharmaceutical, Medical Devices, and FDA regulated environment including Quality Assurance and Process Computer System Validation. * Experience in generating all validation documents, including Validation Plan (MVP), Gap Analysis, Design Specifications, IQ, OQ, and PQ Test Protocols, Standard Operating Procedures (SOPs), and Validation Summary Reports. * Experience in Manufacturing Proces...

Tags for this Online Resume: Compliance, Manufacturing, ISO, Filing, Management, MDR, Process Improvement, Quality, Quality Assurance, Quality Management

Business Analyst - 14 Years of Experience - Near 20850

Tags for this Online Resume: System Security, Test, Test Scripts, Application Development, CFR Part 11, Configuration Management, Configure, Management, Monitoring, Protocol, Quality Assurance

Clinical Pharmacovigilance/Drug Safety

A successful Documentation Control Management professional with over 30 years of experience in the Pharmaceutical and Medical Device industry. Excellent communication and interpersonal skills. Committed to motivating and empowering employees to consistently meet or exceed customer expectations and business needs with the following experiences: Quality Management Systems (QMS) development and implementation (QMS was based on...

Tags for this Online Resume: BPI, Documentum, Document Control, Management, Project Management, Documentation Management, Pharmaceutical, Medical Device, Biotech

Not Listed - 20 Years of Experience - Near 07936

SUMMARY I have a Quality Assurance background (various areas of QA) with experience managing and overseeing QA processes in a Pharmaceutical and Medical Device regulated environment. Produce statistical documentation and communicate with senior-level managers regarding Quality Assurance/Training issues. Provide supervision and training to QA group members. Sustain quality and compliance levels. I am skilled in the following...

Tags for this Online Resume: Manufacturing, Test, Management, Audit, Validation, Database, Documentation, Microsoft Office, Quality, Quality Assurance, Investigations, Microbiologist

Director - 8 Years of Experience - Near 21740

SUMMARY Senior Director/Manager with experience leading multiple departments and disciplines and the ability to create cooperative alliances among organization leaders to support key business initiatives. Proven ability to meet goals and build and retain high performance teams by hiring, developing and motivating skilled professionals. ACCOMPLISHMENTS Managed multiple functional areas, including Quality, Communications, Tec...

Tags for this Online Resume: Assessments, Metrics, ISO, Quality, Communications, Marketing, Audit, Business Development, Clinical Programs, Legal, Hagerstown, Frederick, Martinsburg, Chambersburg, Cumberland