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Online Resumes with "13485"
Quality Coordinator - 5 Years of Experience - Near 08817
PROFESSIONAL PROFILE SUMMARY * A Quality professional with over twenty years' experience in Pharmaceutical and Biotechnology industries. Expertise in pharmaceutical, biological and aseptic manufacturing of sterile injectable and non sterile drug products with an emphasis on regulatory compliance including deviation review (laboratory and production), FDA inspection readiness, quality systems and cGMP compliance. Implemented...
Tags for this Online Resume: Management, Compliance, Reviews, Pharmaceutical, Audit, Documentation, Quality Assurance, Test, Manufacturing, manufacturing, production, reliability, mechanical engineer, electrical engineer, machine operator, maintenance, die cutting
Engineering Manager - 20 Years of Experience - Near 55378
Summary Over twenty (20) years' experience in product development and manufacturing of plastic molded components, assemblies, and finished devices for the Medical Device Industry. Strong background and experience in DMF, part design, mold design, and medical molding. Other key skills include: * * Engineering Management * Program Management * New Product Development * Class "A" Toolmaker and Mold Designer * Injection, Insert...
Ideal Companies: 3M, Colder Products, Entegris
Tags for this Online Resume: Product Design, Tool Maker, Tooling, Procurement, Manufacturing, MCAD Solidworks, Medical, Medical Devices, Product Development, Sales
Purchasing Agent - 20 Years of Experience - Near 80021
St Supply Chain professional seeking a position within a solid manufacturing company. Experienced in all aspects of Materials Management.
Tags for this Online Resume: ISO 9001, Logistics, NPI, Purchasing, ISO, Planning, Management, Inventory, Procurement, Project Management, manufacturing, "project management", production, Supply Chain, Cost Improvement
Quality Manager - 20 Years of Experience - Near 28314
PROFILE Quality Management professional with experience in Quality Engineering and Regulatory Compliance for Pharmaceutical, Medical Device, Automotive, and Aerospace products industry. Strengths include combining technical writing skills with business expertise to streamline processes while complying with domestic and international requirements. Results-oriented, consistently delivering high quality outcomes and recognized...
Tags for this Online Resume: Aerospace, Defense, Quality Assurance, Test, ISO, Audit, Automotive, Complaints, Compliance, Packaging
Life Scientist
SUMMARY: * More than 21 years of excellent experience in Medical Device & Pharmaceutical companies in the area of Process engineering, process Validations, Equipments Qualifications (IQ/OQ/PQ), Process Development Cleaning Validations, New Product Developments, Product and process Technology transfer, Troubleshooting Processes, and in Medical Devices, Product Testing. * Extensive experience in Quality assurances: Auditing, ...
Tags for this Online Resume: Risk Assessment, Quality, Corrective Actions, Process Improvement, Technology Transfer, Audit, Management, Training, Change Control, Good Manufacturing Practices
Life Scientist
SUMMARY: * More than 21 years of excellent experience in Medical Device & Pharmaceutical companies in the area of Process engineering, process Validations, Equipments Qualifications (IQ/OQ/PQ), Process Development Cleaning Validations, New Product Developments, Product and process Technology transfer, Troubleshooting Processes, and in Medical Devices, Product Testing. * Extensive experience in Quality assurances: Auditing, ...
Tags for this Online Resume: Risk Assessment, Quality, Corrective Actions, Process Improvement, Technology Transfer, Audit, Management, Training, Change Control, Good Manufacturing Practices
Mechanical Engineer
Summary: * Results-driven Manufacturing & Product Engineering Professional with a strong background in process development and validation, technology, product transfers, fixture design, development, and validation within highly regulated medical device environments including optical, opto-mechanical, and electro-mechanical systems and devices. * 10+ Years' Experience in writing validation/verification protocols and reports,...
Tags for this Online Resume: Manufacturing, Documentation, Purchasing, Test, Critical Care - Vascular, ISO, ISO 9000, LAPAROSCOPY, Product Development, Urology
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
Director of Quality - 24 Years of Experience - Near 11801
Professional Summary Highly effective professional offering 30 years of US global quality leadership experience developing strategies, improvement action plan and solutions. Dedicated leader to bring organizations together, focusing on hi performance culture leading to improvement and efficiency. Built fully engaged team that is motivated to achieve metrics and deliver ROI. Lead and empowered cross functional teams to impro...
Ideal Companies: end of the year 449.00 + 4 months of our service. resume rewtire and cover letter.
Tags for this Online Resume: TQM (Total Quality Management), Manufacturing, Assessments, Audit, Quality, Quality Management System, HACCP, Continuous Improvement, PCQI, Supplier site and internal audits, USDA, FDA, ISO 9001, SQF, BRC, ISO 22000, ERP, OOS, Investigation, CAPA, NCR
Quality Engineer
Summary of Qualifications Manufacturing engineering, experienced in both Research and Development (R&D) and operations. Generated Protocols and reports documenting validation of manufacturing equipment and processes to satisfy both FDA and CE requirements (e.g., IQ, OQ, PQ, ). Participated on a R&D team that brought new products to market from concept to finished goods. Conceptualized automation of a syringe manufacturing l...
Tags for this Online Resume: Evaluate, Manufacturing, TIP, Automation, Engineering, ISO, Lean Manufacturing, Manufacturing Engineering, Microsoft Windows CE, Research
Principal Quality Engineer, CAPA, New Product Development
Searching a position as senior/principal quality, manufacturing, R&D engineer focused in mitigation, remediation, redesign and process change for cost savings and product quality enhancement, CAPA initiation and execution, and new product development.
Ideal Companies: medical or Aerospace industries
Tags for this Online Resume: Manufacturing, Medical Devices, Product Development, Research and Development, R&D, IQ/OQ/PQ, Pfmea, Dfmea, Certified Quality Auditor, Six Sigma/ Lean Sigma Green Belt, Quality Foundation Deployment Green Belt, MiniTab, Managing Cross Functional Teams, Solid Works Design, Conceptual Design, New Product Development, Risk Analysis, Negotiations, Customer Relations, Value Engineering, Decrease Field Failure, Increase Customer Satisfaction, Report writing, Authoring and enhancing Standard Operating Procedure, ISO 13485, ISO 14971, ISO 60601-1, Authoring Quality Manual, Design Validation, Verification, Valves, Switches, Linkages and mechanism design and development, Complaint Handling
