CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "Iso 13485"

Quality Assurance Director - 17 Years of Experience - Near 03062

SUMMARY A resourceful, determined and results driven global quality assurance & regulatory affairs leader with 17 years of experience in R&D, internal & contract manufacturing operation (CMO), supporting domestic & international markets.

Tags for this Online Resume: Product Development, Engineering, Management, Manufacturing, Reviews, Risk Management, Kaizen, Regulatory Affairs, Automation, Compliance, compliance, ASQ, ISO 13485, Design Control, CAPA, Quality Management System, 510k

Plant Manager - 15 Years of Experience - Near 72000

Career Summary A challenging position and active involvement in a progressive organization offering the opportunity to fully utilize proven and developing skills. Summary of supportive Qualifications * 15 years of experience in Quality Assurance/Quality Control/Quality System * Excellent skills in Quality processes, Design Concepts (Risk Management) and Problem Solving. * Regulatory compliance (FDA QSR, CMDR, IS013485, MDD....

Tags for this Online Resume: Quality Assurance, Audit, Medical, Compliance, DFMEA, Documentation, manufacturing, ISO13485, Plant Management, Test, Quality Assurance Medical Device

Quality Engineer - 5 Years of Experience - Near 91343

SUMMARY OF PROFESSIONAL EXPERIENCE: * Hands on experience on all kinds of environmental Test, EMI & ESD Test for 12 years. * Extensive experience in Electro Mechanical Environmental Test including Design Validation and Product verification for Automotive, Aerospace equipment, Electronic Device (iPhone) &Medical Device. * Hands on working Experience on All kinds of Valve and actuator for Aerospace & Automotive Industry 8 yea...

Tags for this Online Resume: Automotive, Process Improvement, Data Management, Management, Manufacturing, SAP, PPAP, APQP, Lean Manufacturing, Aerospace, Quality Eng, Suppliers Quality Engineer, manufacturing, "project management", production

Quality Assurance Specialist - 7 Years of Experience - Near 55446

SUMMARY: * Around 7 years of experience in Software Testing in Web based Application, Insurance, Healthcare and Banking Applications. * Proficiency in defining, formatting and executing Test Cases based on Business Requirements Ensuring the Traceability for the requirements throughout the testing process. * Good knowledge with Medial Devices (such as ISO13485 standards, IEC60601, FDA processes such as PMA, 510k, Validation ...

Tags for this Online Resume: Java Programming Language, Test, Test Cases, Microsoft Windows, Structured Query Language, Management, Regression Testing, Test Plans, Acceptance Testing, Agile, sql

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 Manager - 20 Years of Experience - Near 11367

Summary of qualifications Senior Certified Quality Assurance Engineer with Mechanical Engineering background over 26 years experience of developing, implementing, auditing, training and managing ISO13485, ISO9001-2015, AS9100D Boeing BAC 5578 and more. Based quality divisions in manufacturing. Extensive knowledge and experience in working with Aerospace and Firearms ind. companies. Provide Quality Engineering support for sp...

Tags for this Online Resume: Management, Quality Assurance, Test, Calipers, Manufacturing, Micrometers, Training, Audit, CNC, Complaints, mechanical engineer, production

Health Technologist - 0 Years of Experience - Near 11746

SUMMARY Senior Quality and Regulatory professional experienced in high tech and medical device manufacturing industries. Progressive responsibilities in all areas of Quality Systems in the implementation of TQM, SPC, Six- Sigma, re-engineering, Continuous Improvement, Quality function deployment, implementation of FDA-GMP or QSR, ISO-9001, EN-46001, ISO 13485, EC Directives for CE marking on products, Clinical trial and Pro...

Tags for this Online Resume: Management, Medical, Operating Room, Policies and Procedures, Project Management, Rf, Software, Software Development, Surgical, Test

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 Supervisor - 18 Years of Experience - Near 11434

SUMMARY A professional Quality Control and Quality Assurance Engineer/Specialist with 9 years of experience implementing and improving quality management systems/ programs to support Manufacturing, instrumentation, Validation, and processes Quality Management Systems and Information Management Systems Qualification Summary: Quality Assurance (manufacturing) * Experienced in ISO 9001 and ISO 13485 standards to ensure that pr...

Tags for this Online Resume: Quality Assurance, Test, Database, ISO, Management, Manufacturing, Procurement, Quality, Quality Control, Quality Management, manufacturing, production

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 Manager - 20 Years of Experience - Near 37921

Professional Summary Senior Quality Manager (BS Eng) with over 30 years of experience in metalworking industries. Responsibilities involve implementing and upgrading Quality Management Systems, managing QMS procedural and cultural turnarounds, executing continual improvement and operational excellence initiatives, improving quality, and reducing costs. Experience has led to extensive knowledge of ISO9001, TS16949, ISO13485 ...

Tags for this Online Resume: Management, Engineering, Quality Assurance, Statistical Analysis, Test, Quality, Automotive, Manufacturing, TS16949, ISO13485

Quality Engineer - 4 Years of Experience - Near 80918

Summary of experience Extensive experience in Medical Device Design, Development and Manufacturing Quality: New product Design experience: 10 new product design projects, and over 30 product redesign projects Design Input: VOC, Risk Analysis (HA & dFMEA), MRD, DRD Design Output: Verification & Validation testing (ex - & in-vivo, human factors & clinical) Mfg. Qualification experience: IQ/OQ/PQs, DOEs, MSAs, GR&Rs Six-Sigma ...

Tags for this Online Resume: Product Development, Reliability, Evaluate, Product Development, Quality Assurance, Reliability, MicroElectronics, Silicon Wafers, Test, DFMEA, Quality, Quality Engineering, Medical Device, Medical device product development, Continuous Improvement, Supplier Quality, project engineer, project manager