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Online Resumes with "13485"
Biomedical Engineer - 14 Years of Experience - Near 92563
Career Summary My current job is Verification & Validation (V&V) Manager for the California High-Speed Rail project. I am responsible for managing the requirements database, V&V status reporting, and requirements traceability for the California Rail Builders. I possess considerable experience with ISO 13485 Quality Management System for medical devices standard and ISO 14971:2012 Medical Device Risk Management. My backgroun...
Tags for this Online Resume: ISO, Acceptance Testing, Account Manager, Integrate, Logistics, Manufacturing, Services, Test, Assessments, Critical Care - Vascular, electronics, Metrology
Biochemist - 18 Years of Experience - Near 44202
Professional Summary I have over ten years of experience in the Biotech industry in both Research and Development and Quality Control). Accomplishments/Skills Technical experiences skills including: * Protein purification using anion exchange, affinity, HIC and SEC as well as HPLC. * Operation of an Agilent and Water's HPLC * Operation of the GE AKTA and Bio-Rad NGC FPLC systems * Cloning and expressing proteins in E. coli....
Tags for this Online Resume: Process Improvement, Troubleshooting, High Performance Liquid Chromatography (HPLC), Quality Control, Research, Manufacturing, Protein Purification, Protein Analysis, ELISA Assay, Western Blot analysis, qPCR/PCR, Cloning, cGMP
Quality Manager - 20 Years of Experience - Near 93030
To expang my knowledge and also teach others on Quality Standards, Processes, and Techniques for better flow.
Tags for this Online Resume: Quality, SPC, ISO 13485, ISO 9001, ASQC, ANSI Y 14,5, CA., Quality Assurance, Quality Control, CMM (Capability Maturity Model), manufacturing
validation/quality/manufacturing engineer
PROFESSIONAL SUMMARY: * Experienced as validation engineer and experience in Process Validation, and Test Method Validation in compliance with FDA standards * Expertise in writing Test method Validation Protocols (TMV-P) and executing the protocols * Experienced in validating different types of test methods (Attribute Test Method, Variable Destructive Test Method, Variable Non-Destructive Test Method, Analytical Test Method...
Tags for this Online Resume: Reviews, Root Cause Analysis, Test, Assessments, Documentation, PFMEA, R&R Report Writer, Regulatory Affairs, Reliability, Risk Assessment, manufacturing
PROJECT MANAGER
Career Summary * Over a decade of experience with medical device manufacturing, inclusive of the following: * Project Management, specifically New Product Development * Design Engineering and Control * Manufacturing Engineering and Six Sigma Manufacturing * Process Development and Statistical Process Control * Quality Management, Testing, and IQ/OQ/PQ Validation * Regulatory Compliance and GMP (FDA Class I, II, and III devi...
Tags for this Online Resume: Billing, Compliance, Documentation, Engineering, Management, Medical, Medical Devices, Process Control, Program Manager, Quality, PROJECT MANAGER, PROJECT ENGINEER, MANUFACTURING ENGINEER, MEDICAL DEVICE MANUFACTURING, REGULATORY COMPLIANCE, DESIGN & DOCUMENTATION, OPERATION MANAGEMENT, SALES & MARKETING
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
Director of Quality
Summary Dedicated professional with 20+ years' experience in Integrated Management Systems, including Quality (ISO 9001), Environmental (ISO 14001), and Health & Safety (OHSAS 18001) with 12 of those years as Head of Quality Management in different industries. Broad experience in MS-Office, MS-Visio, project-management and SAP, cGMP, FDA 21 CFR part 820, ISO 13485, ISO / IATF 16949, IRIS, supplier management and all aspects...
Tags for this Online Resume: R&R Report Writer, Automotive, Management, Quality, Quality Assurance, Quality Management, ISO, ISO 9001, Documentation, Project Management
Electrical Engineer
SUMMARY: Multidisciplined Electrical Engineering background with wide experience in Product Safety and EMC/EMI compliance procedures and tests Design, Research, Testing, System development, integration and implementation, Product and Quality Systems Certification ( ISO 9001/9002, ISO17025, ISO 13485), analysis and considerations of corrective and preventative actions (CAPA) for Electrical, RF, Telecommunications and Medical...
Tags for this Online Resume: Electronics, Research, Siemens, Systems Analysis, Xerox, Integrate, Quality, Test, ANSI, Ansi (Am Natl Stds Inst)
Department Manager - 20 Years of Experience - Near 02901
SUMMARY: Supply Chain / Manufacturing professional with broad experience in all phases of technology manufacturing and operations. Specializing in medical device/ISO13485 environments to include, instrumentation manufacturing, project management, supply chain management and ERP systems implementation and support. Adaptable, hands on and excels in a rapidly developing environments with focus on startups.
Tags for this Online Resume: Instrumentation, Purchasing, Inventory Control, Supply Chain, Medical Device, Startup, Manufacturing, Operations
Quality Manager
CAREER SUMMARY Ethical, strategic, and transformational leader who engages teams to deliver business results and drive sustainable excellence. Engineering Professional/Lean Six Sigma Black Belt with over 20 years + of experience in Quality, Supplier Quality, Process Engineering, and Kaizen/Lean Manufacturing in Food MFG/HACCP., Good Manufacturing Practices (GMPs), Vertical Pump Application, Global Drive Systems, elevators, ...
Tags for this Online Resume: Process Control, Management, SPC, ISO, Policies and Procedures, Project Management, Project Manager, Quality, Quality Assurance, Quality Management
Manager - 15 Years of Experience - Near 49444
COVER LETTER: To whom it may concern: I am very interested in discussing opportunities within your organization. I feel my background and experience will enable me to adapt quickly to become an asset to your company. * Self-starter, highly motivated, dedicated, disciplined, and goal oriented person. I have been in Quality for over 20 years. I am a Certified ISO Quality Lead Assessor (R.A.B.). I am also a Senior Member of th...
Tags for this Online Resume: ISO, APQP, CMM (Capability Maturity Model), Quality, Quality Assurance, Corrective Actions, Plastics, PPAP, Services, 5S, reliability, electrical engineer, manufacturing, production
Program Manager - 0 Years of Experience
Career Summary * Over a decade of experience as a Project Manager, primarily in the medical device industry, and inclusive of the following professional skills: * Project Management and New Product Development * Product Design & Engineering (for manufacturability, DFM) and Engineering Change Control * GMP, Good Manufacturing Practice, and Lean Six Sigma Manufacturing * Process Development and Statistical Process Control * I...
Tags for this Online Resume: Training, Billing, Change Control, Compliance, Documentation, Engineering, Management, Medical, Medical Devices, Process Control, manager, civil engineering, architecture, construction management
