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Online Resumes with "ISO 13485"
Looking for a company that recognizes the value of continuous improvement I have used the Six Sigma DMAIC methodology to eliminate non-value added activities. Visit customers to share process knowledge and answer technical questions. Work with suppliers to identify defect root cause and verify corrective actions are effective. Qualify new suppliers. Industries: Plastics, Chemical, Automotive
Tags for this Online Resume: Supervision, SPC, Design of Experiments (DoE), Value Stream Mapping, Continuous Improvement, Six Sigma, Kaizen, Poke Yoke, Suppler Quality Engineer, SQE, Internal Auditor, AutoCAD, ISO 9001:2000, ISO/TS 16949:2002, ISO 13485:2003 Medical Devices, Quality Engineer, Minitab, APQP, PPAP, FMEA, Control Plans, Preventive Maintenance, CMM
To further my career in Supply-Chain Mgmt and Purchasing by offering 7 years of process improvements and cost saving strategies. I earned a Bachelors degree in Business Management with woking knowledge of FDA 21CFR820, ISO 13485, and ISO 9001.
A highly motivated professional with more than 28 years of successful experience in the development, training, implementation, and maintenance of various quality management and continuous improvement systems. A Dynamic, energetic leader dedicated to developing, mentoring, and coaching. Overview: • Expertise in consumer, regulatory, and industrial quality standards and CI/Lean Manufacturing processes, Quality Manageme...
Tags for this Online Resume: CI/Lean Manufacturing processes, Quality Management Systems, AS9100, Quality Assurance and Control, Supplier Quality Management, Quality System Auditing, Quality Planning, Department Management, Operations Management, Project Development, Product Development, Motivation and Training, Customer Relations, Problem Solving, D1-9000, SSQA, ISO9001:2000, ISO9001:2008, TS16949, ISO13485, Process Improvement, Kaizen, 5S Technique, Value Analysis, Failure Mode and Effects Analysis (FMEA), Process Capability/SPC, Specification, Measurement and Process Capability, Flowcharts, Pareto charts, Fishbone, Improvement Techniques, Quality Circles, Root Cause Analysis, Six Sigma, Quality by Design, Design of Experiments, Seven Tools of Quality, Control Charts and Graphs – SQC, Advanced Product Quality Planning (APQP), PPAP
Contribution over 20 years of experience ensuring continuous improvements to deliver manufacturing and quality efficiency, I am writing in response to a Food Safety & Quality Management System and Regulations Affairs opportunity. Able to define, analyze, and improve complex applications, established effective food safety, quality regulatory, sanitation, and operational programs. I bring extensive knowledge, experience, pro...
Tags for this Online Resume: Quality Management Systems, Food Safety Fundamental Specialist, Certified Quality Management, Certified Quality Engineer, SQF Specialist, Lean Manufacturing & Continuous Improvement
I am known as a volume producer; task orientated, detailed and very organized who readily adapts to rapidly changing priorities.
I am experienced in the fields of Documentation and Change Control Systems, Design Controls/Audits and Risk Assessment Analysis / Management, Project Leader, Accounting, and Data Processing.
Ideal Companies: Stable
Engineering Manager - 10+ years experience - ISO-13485, 21 CFR 820/211, cGMPs, Lean/Six Sigma, Project Management.
To obtain a management level Engineering/Manufactiring/Operations within regulated Medical Devices/Biotech/Pharma/Food Industry where I can utilize past experience in Manufacturing support, process developement, process improvement and product sustaining.
Quality Assurance professional with over 20 years of experience in highly regulated manufacturing environments (disposable medical devices) from start up to fully operational business settings. Knowledgeable and skilled in the implementation and operation of Quality Systems and Quality Standards based working environments. Fully capable to work within, develop, or lead a company’s Quality Assurance, Quality Engineering an...
Consultant, Project Lead, R&D
I am a Quality Manager with extensive expertise that has produced results in supplier development, process evaluation, testing procedures, and quality systems development for KEIPER, LLC. I have acquired significant experience with a proven track record in the quality arena. I am fluent in the lean/sigma tools, and lead many continuous improvement events. I also have experience in the implementation and compliance of cu...
I am seeking a like position with both challenge and room for unique contributions my background and experience can bring. I am willing to relocate for the right opportunity.
Ideal Companies: New Start-ups
Tags for this Online Resume: Company-Wide Quality Systems design, development & Certification to FDA/QSR, ISO13485 and all other associated regulatory requirements in both domestic and international markets for a broad range of Class I, II & III Medical Devices, Documentation/Data Control Management – CFR21 Part 11 Compliant, Develop/Manage Contractor-Supplier-Customer Partnerships (Internal & External) for Custom & Off-the-Shelf materials and components fabrication, assembly, sterilization, packaging, storage & distribution from Domestic & Global resources, Strategic Planning for Products / Budgets & P/L Responsibility, Lead Auditor for External QS Audits / Develop & Manage Internal Audit Programs, Post Market Surveillance Management, including Customer Service & Compliant Handling, for Continuous Improvement Program
To obtain a position in Quality Control and Regulatory Compliance in a Pharmaceutical or Medical Device company.