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Online Resumes with "iso13485"



Featured Profile

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

Featured Profile

Experienced Quality Assurance Engineer

Experienced Quality Assurance Engineer With demonstrated history of working in the consumer electronics industry, Skilled with HP,JIRA, Quick Test Professional(QTP), RMA Agile Methodologies, And detail knowledge about FDA procedures in Quality Engineering.

Tags for this Online Resume: MySQL, Java, Jira, ISO 13485, FDA, Systems Testing, C#

Featured Profile

Senior Operations - Product Integrity - Quality - Compliance - Far East - Europe Success - 6 Sigma LEAN

Senior Manager - Product Development or Quality / Compliance or Operations, capable of Broard Contribution scope - for Consumer Product Related industry retailer, OEM or Service provider. Seeking turn-around situation or growth organization

Tags for this Online Resume: Compliance, Regulatory Compliance, Director Operations, Manufacturing, Quality Assurance , Product Safety, Product Integrity, Management, Consumer Products, Complaints

Featured Profile

Manufacturing and Operations Leader

Highly adept business leader with a strong track record of successful change management in manufacturing and engineering based organizations. Demonstrated ability to excel in management roles with progressive responsibility. Robust background in all areas of Operations management with over 20 years of experience focused on NPI, Lean deployment, site transfers, cost reductions, and QMS compliance. Energetic, people-oriented...

Ideal Companies: Medical Device manufactures

Tags for this Online Resume: Change Management, Coaching, Engineering, Kaizen, Leadership, Management, Manufacturing, Manufacturing Engineering, Medical Devices, Inventory Management, Business Process Improvement, Lean, Continuous Improvement, Quality System, Supply Chain, Warehousing, Process Management, Budget Management, Organizational Develpment, Servant Leadership, Cost Savings, Capital Acquisitions, Plant Leader

Featured Profile

Clinical Regulatory Affairs - 20 Years of Experience - Near 80023

SUMMARY OF PROFESSIONAL EXPERIENCE Regulatory, Quality, Clinical and Compliance Medical Executive with major milestones/achievements in the Life Science Industry. Over 30 years in Class III and Class II devices/allograft/biologics, inside/outside the United States (OUS) primarily in the fields of cardiology, cardiovascular, neurology, spine and orthopedics. Integral involvement with 80+ product categories. Personally prepar...

Tags for this Online Resume: Medical Device, Regulatory/Quality, Clinical, Audit, Distribution, Budgeting, Microsoft Windows CE, Advertising, Cardiovascular, Compliance, clinical, trial, protocol, ich, FIM, EFS, gcp

Quality Assurance Director - 0 Years of Experience

Engineering professional with in depth work experience in lean manufacturing, process engineering, research and development, quality assurance, Quality System programs including CAPA, Audits, Supplier Quality, RiskManagement, Complaint Investigations and Document Control. * Experience in root cause analysis, developed testing strategies to support test executions, process verification/ validation, Assembly line, Current/new...

Tags for this Online Resume: Manufacturing, Product Development, Reliability, Root Cause Analysis, Statistical Analysis, Assessments, Compliance, Documentation, Engineering, Evaluate

Featured Profile

Manager - 15 Years of Experience - Near 60081

Highly experienced senior quality professional with twenty years in Quality Management and Quality Engineering. Specific experience in medical device, automotive, consumer product, and compliance with ISO 13485, TS16949, and 9001:2015. A champion of continuous improvement and an effective Kaizen leader with a track record of achieving significant improvement in Quality, Cost, and Delivery metrics in cross-functional and mu...

Tags for this Online Resume: Manufacturing, Quality Assurance, Management, Quality, Quality Management, NPI, Assessments, Process Improvement, ISO, ISO 9001, Financial Acumen, Multi-site experiance, Cross-functional leader, Culture change

Featured Profile

Lean Six Sigma Master Black Belt, Change Manager, Supplier Quality Partnership, Voice of Customer liaison, Business Quality Management Champion, Mentor, Trainer

Lead employees and management by example to Quality 4.0 excellence. Drive Quality principles into design and processes reducing inspection through managed controls. Implement and sustain process controls through lean six sigma methodology. Allow quality system metrics to demonstrate the business performance to interested parties, regulatory agencies and customers.

Ideal Companies: Abbot, Medtronic, Meggit, ITT Controls, Forrest Machine, Enersys, Boeing, Lockheed, Northrop, CPP, Valence

Tags for this Online Resume: Quality Assurance, Document Control, ISO 9001, Supply Chain, Audit, Automotive, Change Manager, AS9100, FAA Repair Station, Lean Six Sigma Master Black Belt, Project Management, Supplier Management, Problem Solver, Microsoft Office

Quality Manager - 20 Years of Experience - Near 79936

Tags for this Online Resume: Manufacturing, Quality, Quality Assurance, Test, Inventory, Kanban, Lean Manufacturing, Complaints, Quality Control, SPC

Quality Engineer

Tags for this Online Resume: Manufacturing, SAP, Support, Agile, Agile methodology, Documentation, ISO, NPI, Router, Automotive

Medical or Health Services Manager

Tags for this Online Resume: Chemistry, Management, High Performance Liquid Chromatography (HPLC), Scheduling, Documentation, Services, Test, Electrophoresis, HP, Microsoft Excel

Quality Manager

Tags for this Online Resume: Quality Assurance, Test, Audit, Automotive, Process Improvement, Product Development, Protocol, Publications, Research, Research and Development