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Online Resumes with "ISO 13485 2003"
Quality Manager - 20 Years of Experience - Near 37129
SUMMARY * Conduct medical device, cosmetic and pharmaceutical excipient and APIs, and supplier certification, evaluation and qualification activities, including on-site and desktop assessments of quality systems, product and process controls develop control plans for monitoring supplier corrective actions for quality, performance and delivery, employing standard industry tools (pFMEA, root cause investigation, lifecycle man...
Tags for this Online Resume: Instrumentation, Diagnostics, ISO, ISO 9001, Management, Document Management, Software, Assessments, Engineering
Director of Quality - 20 Years of Experience - Near 91325
Summary of Career Milestones: * BS degree in Industrial Technology. Final semester of a combined Masters Program * 25 years in various manufacturing environments including electro-mechanical, medical devices and Aerospace/Defense * Lean Six Sigma Master Black Belt Certified (LSSMBB) (Global Cert - Germany and Villanova University) * Multiple Quality related certifications from ASQ, ASNT, RAB, IRCA, SME. * Certified Internat...
Tags for this Online Resume: Test, Engineering, Reliability, Management, Manufacturing
Quality Engineer - 11 Years of Experience - Near 97220
PERSONAL SUMMARY An experienced Quality Assurance professional with specialization in systems audits, both internal and external. Extensive experience with driving improvements, streamlining processes, cutting costs and ensuring compliance with procedures. Strong analytical skills and a practical approach to problem solving, combined with excellent communication, training and presentation skills. An ability to build and lea...
Tags for this Online Resume: Assessments, Compliance, Management, Quality, Quality Assurance, Quality Control, Risk Management, Test, Training, Data Analysis
Quality Assurance Director - 20 Years of Experience - Near 33545
BSI ISO 13485:2003 Lead Auditor (TPECS) Certification - Certificate: 7930649-76913 * Hired and entrusted by B Braun McGaw of Puerto Rico and LeMaitre Vascular to implement a wide-array of corrective actions and systems resulting from 3 FDA warning letters. Subsequently after new systems implementation received 0 FDA 483 observations for a combined period of 12 years. * Built company-wide shared quality visions which complet...
Tags for this Online Resume: Documentation, Quality Assurance, Compliance, Pharmaceutical Industry, Quality, Quality Control, Regulatory Affairs, Medical Devices, Pharmaceuticals, Regulatory Compliance
Quality Engineer
Summary To contribute my Engineering, Management, Client service, Computer Application, Continuous process improvement, quality management, and manufacturing operations expertise to a successful and growing organization. Expertise * Significant expertise with Continuous Improvement and Quality Tools, including Histograms, Pareto, Gantt Charts, and Flow Diagrams * Lean Manufacturing and Kaizen Event experience * Proficiency ...
Tags for this Online Resume: Quality Assurance, Training, 5S, CMM (Capability Maturity Model), Kaizen, R&R Report Writer, Data Analysis, Failure Analysis, Management, Root Cause Analysis
CAD Engineer - 8 Years of Experience - Near 60634
QUALIFICATIONS * ProE (08/2010) * ISO 13485:2003 * SolidWorks (08/2010) * AS 9100C * AutoCad (08/2010) * Design layout and part number creation * Rapid Prototyping/3D Printing * Researching cost saving measures for new products * Aviation QA Inspector (01/2004) * Implementation of design improvements * ISO 9001:2008 * Rotationally Molded Parts
Tags for this Online Resume: MCAD Solidworks, Product Design, Assembly Line, Support, Punch Press, Autocad, Autodesk AutoCAD, English Language, ISO, ISO 9001
Clinical Quality Assurance - 20 Years of Experience - Near 46360
Managed Quality Control / Quality Assurance / Regulatory Affairs departments in different roles for different companies for manufacturing packaging and distribution of drugs and devices. Designed flow processes for improvement of quality of products and quality of documents using proper validation protocols and procedures. Built quality management systems three times upgrading: Customer complaints investigations document co...
Tags for this Online Resume: Quality Assurance, Test, HYGIENE, Management, Publications, Quality, Six Sigma Quality, Packaging, Corrective Actions, Instrument Calibration, protocol, pharmaceutical, preventive maintenance
Clinical Quality Assurance - 13 Years of Experience - Near 92057
QUALIFICATIONS: Over 13 years of experience in the Pharmaceutical and Medical Device Industry. I have a proven desire to enhance team effort and first time quality concepts, Strong creative research skills, Strong detailed and task oriented skills. Work environment regulated by 21 CFR 820 and ISO 13485:2003 & 9001. Specialized in Quality Assurance, Regulatory Compliance, GMP, Document Control, QSR training, Excel, Power Poi...
Tags for this Online Resume: Compliance, Accounts Receivable, Customer Service, Inventory, ANSI, Ansi (Am Natl Stds Inst), Training, Audit, Document Control, ISO
Masters in Biomedical Engineer, Irvine
Tags for this Online Resume: quality control, ISO 13485 -2003, biomedical engineer, thermoplastics, medical devices, materials engineer, thermo plastics, autocad, polymer processing, metals, injection molding, regulatory compliance, solidworks, solidworks
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
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
Mechanical Drafter - 20 Years of Experience - Near 94509
Mechanical Draftsman/Designer with 20+ years experience in high-volume, rapidly changing environments. Extensive expertise in mechanical/electrical assembly drawings, bills of materials, electronic and mechanical component specifications. Possess rare background in both electronics and mechanical drafting, including schematics and work in printed circuit board layouts (bare boards and assemblies). Expert in Windchill PLM, ...
Tags for this Online Resume: Adf (App Dev Tool), CAD Tools, Electronics, Document Control, Engineering, Engineering Drawings, Enterprise Requirements Planning, Enterprise Resource Planning, Management, Planning
