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Online Resumes with "FDA ISO"



Prodcution Supervisor-25 years Experience- Riverside/Ontario

A knowledgeable, goal-oriented Production Supervisor with more than 25 years manufacturing experience in FDA and ISO environments. Experienced in both technical and management levels and can effectively communicate quality and process issues to all departments. Strengths include training trainers, leads, and assemblers, setting up Assembly lines for R&D projects, and supporting engineering qualifications for equipment and...

Configuration Management Professional - 20 years experience - Pittsburgh 15235

Detail-oriented, CMII certified configuration management professional offering versatile experience in master data, documentation and change control management utilizing industry standards and best practices. Extensive experience in FDA and ISO controlled environments. Comprehensive knowledge in the development of quality management system procedures, as well as quality audit and remediation process support. Proven team ...

Tags for this Online Resume: configuration management, Document Control, document, process, procedure, change, records, documentation

Engineer - 20 Years of Experience - Near 48237

Experienced Quality Engineer in the Medical device manufacturing. Maintaining QS,FDA and ISO 13485 regulated industry. Hands on experience on inspection and testing.

Tags for this Online Resume: CQE, Coordinate Measuring Machine, ISO 13485, 21 CFR Part 820, CAPA, Complaints, Automation, Automotive, Consulting, Dialysis, Engineering, Internal Auditor, ISO, ISO 9000, Automation, Automotive, Consulting, Dialysis, Engineering, Internal Auditor, ISO, ISO 9000

Quality Engineer - 10 Years of Experience - Near 29505

I spent over 10 years working as a Mechanical Engineer. The industries include building MRI unit, nylon fiber and Mylar film production. The following manufacturing process skills were obtained: Six Sigma, Lean Manufacturing, Kaizen, FDA and ISO Quality standards, Ergonomic Safety engineering, Supplier Quality Auditing, Auto CAD. After these experiences, I moved to China to learn Mandarin Chinese and start up my own comp...

Tags for this Online Resume: Bilingual, Mandarin, Chinese, Six Sigma, Lean, Supply Quality, Engineer, Manuafacturing

Featured Profile

IT Field service Engineer Consultant / Intelligent Technology

A challenging position as a Communications Consultant in a the bio-medical intelligent Technology. 7+ years of experiences

Ideal Companies: Looking for Company with improvement of growth and ownership of a franchise etc.

Tags for this Online Resume: Peripheral, palm Pilot etc.

quality assurance supervisor 15+ years expeirence, BRC certified

Quality assurance management professional: Establishes strong peer relationship between senior and production team successfully manages projects and audit procedures that exceed government and company policies, compliance expertise in USDA,FDA,ISO,HACCP,GMP,SSOP, and safety regulations

Tags for this Online Resume: Atlanta, quality assurance with 15 years, BRC certified, safety manager experience

Operations Manager - 18 Years of Experience - Near 97013

Dynamic, results oriented Medical Device Manufacturing Operations Executive who has demonstrated the ability to lead diverse cross-functional teams to new levels of success in medical device manufacturing. Strong analytical, technical and business qualifications with an impressive track record of more than 16 years of hands-on experience in strategic planning, business unit development, project and product management, and s...

Tags for this Online Resume: FDA, ISO 13485, 21 CFR 820, cGMP, Medical Device, Manufacturing, Operations, Production, Development Activities, Documentation, Medical, Medical Devices, Sourcing, Enterprise Requirements Planning, NCR, SAP, Development Activities, Documentation, Medical, Medical Devices, Sourcing, Enterprise Requirements Planning, NCR, SAP

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

Clinical Quality Assurance - 17 Years of Experience - Near 27713

QUALIFICATIONS: QA / Quality Oversight, Data Integrity, Investigations, six sigma, CAPAs, TrackWise, Root Cause Analysis (RCA), Technical / Collaborative / Creative Writing, Microsoft Office, Inhalation, Stability, HPLC, Analytical Analysis, Quality Control (QC), Quality Assurance (QA), Audits, cGMP, cGLP, GxP, cGCP, method development/validation, Instrumentation/Automation, software, 21 CFR Part 11, FDA / ISO / Internation...

Tags for this Online Resume: Quality, Investigations, Regulatory, Writer, Raleigh, Data Review, Biotech, Test, Atlas, Automation, Data Entry, Documentation, Manufacturing, Protocol, Quality Assurance

Production Supervisor - 20 Years of Experience - Near 76063

Results driven production manager with over 20 years of leadership experience in multiple manufacturing environments. Flourished in multiple leadership positions in the medical device field with progressive results in quality, compliance, and defect management. Excelled in FDA, ISO, and continuous improvement methodologies. Exceptional leadership, customer service, and process analysis skills.

Tags for this Online Resume: DDallas/Ft.Worth, Supervision, FDA, Quality, Production, GMP

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

Production Inspector

Professional Summary Skills Team leadership, supervisory Quality control, auditor, Kanban s k ills inventory, cycle counting, clean room, line clearance, food industry production, pharmaceutical packaging, data entry, documentation Automotive production/assembly cGMPs, cSOPs, familiarity with operations, plastic injection mold, OSHA, FDA, ISO quality standards, hard-coating lens, metalizing 5s. safety components, ability to...

Tags for this Online Resume: Clean Room, 5S, Automotive, Billing, Communication Skills, Data Entry, Distribution, Documentation, Inventory, ISO, Team Lead, Quality Control, GMP, FDA, OSHA, CHARLOTTE, NC, Customer Service