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Online Resumes with "iso13485"
Environmental, Health & Safety Manager - 12 Years of Experience - Near 17851
Areas of Expertise: * Team Leadership * Project Management * Professional Communications * Complex Problem Solving * Research & Development * Product Management * Process Development * Client Relationship Management * Documentation Management * ISO9001/ISO13485 Quality Standards * Cross Functional Collaboration * Cost Reduction Conductor * Manufacturing Operations * Contractor Management * Sourcing & Procurement * Consultin...
Tags for this Online Resume: Manufacturing, Medical, Management, Project Management, Corrective Actions, Engineering, Quality, Quality Assurance, Root Cause Analysis, Telecommunications, project engineer
Managing Director - 5 Years of Experience - Near 92109
Due my extensive experience in development, manufacturing and commercial release of medical devices (SW/HW solutions) following the FDA/ISO13485 and CE regulations, I'm looking for a role as a Sr.Mgr/Director in Product/Project Mgmt or Operations.
Tags for this Online Resume: Integrate, Forecasting, Business Development, Computer Aided Software Engineering, Networking, Oracle, Ethernet, Forecast, Foundry, Management, management, Product Manager, Program Manager, Project Manager
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
Life Scientist - 20 Years of Experience - Near 30523
QA Manufacturing Compliance Lead Lead QA Validation Remediation - Comprehensive Product and Process gap assessments of HVAC, Utility Maintenance programs, product Scale-up through commercial validation, packaging and manufacturing process failures, and customer complaints for Prescription, OTC & DEA products. Conduct review of CMO validation change control and QC OOS/OOT reports and write annual Product Review for all produ...
Tags for this Online Resume: Training, Project Management, Distribution, Management, Risk Management, CFR Part 11, Design Specification, pharmaceutical, protocol, Leadership, Staff development, cleaning validation, process validation, computerized systems validation, Program Management, QC testing, Chemist, CAPA, NCR, Customer Complaints, Supplier Quality, commissioning, equipment qualification, equipment purchase, Change control, Auditing, Medical Devices class I, II and III, Pharmaceutical development DOE, Pharmaceutical Clinical Scale-up, Mfg./Pkg. Management, ISO13485, Technical Reporting, FDA site QA contact
Quality Engineer
ACCOMPLISHMENTS & ACHIEVEMENTS * Researched and budgeted for a vast array of new soldering tips and equipment, microscopes, and specialized lens accessories, and a CMM in order to significantly improve inspection results. Automated SPC measurement systems that resulted in real-time data collection cost savings of $480,000. * Champion of lean six sigma and continuous improvement techniques within Kaizen culture. Became subje...
Tags for this Online Resume: Audit, Legacy, ISO, Management, Procurement, Quality, Quality Assurance, Quality Management, Test, Compliance
Medical Device, Health Technology
Supplier Quality Management, ISO 13485 and supplier audits
Tags for this Online Resume: Supplier Quality Management, Certified Lean Leader, Certified Quality Engineer, Certified Master Black Belt, Certified Supplier Auditor, Certified Process Validation Expert
Quality Assurance - 15 Years of Experience - Near 92116
If your organization has a strong commitment to quality and has integrity, it would be my pleasure to be considered for employment. I am a creative problem solver with a plethora of diverse skills, talents, and experience.
Tags for this Online Resume: quality, communication, project oriented, multi task, bilingual, Audit, Document Control, Management, Quality Assurance, medical devices, Lead auditor, Manager, compliance, pharmaceutical, sap, gcp, regulatory, validation, GxP
Regulatory Affairs, Quality, and Clinical Evaluation Consultant to Medical Device Industry
PROFESSIONAL PROFILE: A focused, driven, and passionate regulatory affairs and quality/compliance/auditing consultant with hands-on experience in RA and Quality/Compliance/Auditing associated with activities which lead to, and maintain regulatory approval to ISO 13485, FDA 510 (k), EU CE Mark & other international market authorizations of medical device products and conformance/compliance of Quality Management Systems. Regu...
Tags for this Online Resume: Management, Regulatory Affairs, Assessments, Audit, Budgeting, ISO, Microsoft Office, Quality, Quality Assurance, Quality Management, oncology, protocol, 13485, FDA, 483, Warning Letter, Portuguese, Spanish, ANVISA, Lead Auditor, Quality Systems, Quality Audit, Medical Device
Engineer - 20+ Years of Experience - Near 93010
Summary 20+ years' experience in Aerospace, Military, Medical, and Commercial Engineering and Design: Mechanical, Manufacturing, and Quality Engineering (AS9100 Rev C, ISO 9001, NADCAP, ISO-13485, ANSI/ESDS20.20, IPC-610 Certified) involving PCBAs, system integration, Electro-mechanical packaging, precision mechanism design, Manufacturing, and Facilities lean layouts. Six Sigma Green Belt Certification. ASQ Member (Channel ...
Tags for this Online Resume: Manufacturing, Documentation, Medical, Process Improvements, Quality, Quality Assurance, Engineering, Engineering Drawings, Failure Analysis, AS9100, AS9102 FAIR, ISO13485
Chemist - 20 Years of Experience - Near 84341
Areas of Expertise * Batch Record Review * Transfer of Analytical Data (TAP) * GMP & Regulatory Affairs * Remediation * Process Validation * Deviation Resolution * Lab Environmental * CAPA Investigation * Quality Compliance & Assurance * Product Quality Management * Manufacturing of Sterile and aseptic products * 21 CFR, EU Regulations, and ISO 13485 * Safety and Regulatory Compliance * HPLC for API and Finished Product usi...
Tags for this Online Resume: Manufacturing, Pharmaceutical, High Performance Liquid Chromatography (HPLC), Management, Pharmaceutical Industry, Research and Development, Regulatory Affairs, API, Application Program Interface
Quality Manager - 20 Years of Experience - Near 37064
Manager - Accountable for all aspects of ISO 9001:2008 quality management system and quality control. * Lead a staff of 8 quality professionals provided unprecedented level of service to both internal and external customers. * Developed formal validation and design procedures for medical device components compliant to cGMP. * Led all CAPA (RCCA) efforts. Enhanced successful closure by 70% and strengthened root-causes and tr...
Tags for this Online Resume: Science, Acceptance Testing, Protocol, Quality, Quality Assurance, Test, Manufacturing, Corrective Actions
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
