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Online Resumes with "Iso 13485"
Quality Manager - 20 Years of Experience - Near 12534
SUMMARY OF QUALIFICATIONS: Over 25+ years experience in the field of Quality Assurance compliance in a wide variety of analytical laboratories and production settings. Specialization in regulated Quality Assurance manufacturing, compliance testing, packaging, labeling, and distribution of a variety of products.
Tags for this Online Resume: Auditing, Manufacturing, Quality Assurance, Technical Writing, Quality Control, Packaging, Testing, CAPA, Customer Complaints, Documentation, ISO 9001, ISO 13485, "project management"
Quality Manager - 20 Years of Experience - Near 28269
Summary of Qualifications and Accomplishments * Demonstrated excellent Quality Management/ Engineering work experience, providing technical support to customers, suppliers, cross-functional team members, and manufacturing on new and existing products. * Knowledgeable and experienced with SMT, PTH, Hybrid, Chip on Board, Power Supply, and Fiber Optic technologies to assemble, test, and box build printed circuit boards in sup...
Tags for this Online Resume: ISO 9001, Fiber Optics, Quality Assurance, Test, Welding, Capital Equipment, Consumer Products, Engineering, ISO 9001, Fiber Optics, Quality Assurance, Test, Welding, Capital Equipment, Consumer Products, Engineering
Quality Professional
Qualifications Skills: Regulatory Affairs/quality assurance: Projects, related skills and practice include: * Prepare and submit 510 (k) s for US FDA on Class I and Class II Medical Devices and assisted with the preparation of Class III submittals * Compile, document and submit Technical Files for Europe (CE Marking) per Medical Device Directive (MDD) * Perform monthly trending analysis * Developing quality systems plan inc...
Tags for this Online Resume: Manufacturing, Medical, Medical Devices, Risk Analysis, Documentation, Failure Analysis, ISO, Quality Assurance, Quality, Statistical Analysis
Engineering Manager
ACCOMPLISHMENTS * Drove development of new products which allowed the growth of Titan Spine from around $1M annual sales to over $30M in 7 years. * Participated (on a team of 3) in achieving ISO 13485 certification of Titan Spine in 6 months. * Named as inventor on 38 United States Patents for medical devices. * Lead the development and launch of the Charlotte™ Foot and Ankle product line which is the foundation of the extr...
Tags for this Online Resume: Distribution, Medical, Medical Technology, Sales, Management, Packaging, Product Development, Product Launch, Surgical, Development Activities, mechanical engineering, project engineer, orthopedics
Quality Manager/Director - 25 Years Experience - Desire relocation to Nashville, TN
I am a scientifically trained quality professional with over 25 years of experience. As a former military officer, I bring leadership and communication skills and a passion for customer satisfaction and organizational improvement and success. I am a team builder and operate with a hands-on approach.
Tags for this Online Resume: Quality Management, ISO 9001, ISO 13485, Communication Skills, Process Improvement/6 Sigma, Validation, Problem Solving, Science, HYGIENE, Test, Acceptance Testing, Protocol, Quality, Quality Assurance
Quality Manager - 20 Years of Experience - Near 45342
a challenging position utilizing my skills in Quality/Document Control, NEI Six Sigma tools, and Engineering. I feel my experience and background in quality, engineering, and manufacturing are a good fit for a position within your company. We have recently re-located to the Maimisburg area. Advanced Forming Technology: 1992 - 2017 QUALITY ANALYST 2008 - 2017 Responsibilities, Duties and Accomplishments * Company representat...
Tags for this Online Resume: Enterprise Requirements Planning, SAS/STAT, Training, Document Control, QMS Lead Auditor, manufacturing, Document Controller, Quality trainer, Supplier/Vendor auditor, Quality Analyst, RMA tracking
Quality Engineer
Summary To contribute my Engineering, Management, Client service, Computer Application, Continuous process improvement, quality management, and manufacturing operations expertise to a successful and growing organization. Expertise * Significant expertise with Continuous Improvement and Quality Tools, including Histograms, Pareto, Gantt Charts, and Flow Diagrams * Lean Manufacturing and Kaizen Event experience * Proficiency ...
Tags for this Online Resume: Quality Assurance, Training, 5S, CMM (Capability Maturity Model), Kaizen, R&R Report Writer, Data Analysis, Failure Analysis, Management, Root Cause Analysis
Department Manager - 20+ Years of Experience - Open to Relocation
Qualifications: * Goal-driven Servant Leader with broad experience in Quality Technology, Manufacturing, and Lean Initiatives. * Demonstrated record of high performance standards, including attention to schedules, deadlines, and issue resolution with an emphasis on the bottom line. * An effective leader with solid decision making capability and dedicated to "Sending the Right Message". * Ability to effectively lead multiple...
Tags for this Online Resume: Architect, Manufacturing, ISO, ISO 9001, Management, Microsoft PowerPoint, Quality, Quality Assurance, Quality Management, Development Activities
Director of Quality & Regulatory- 22 Years of Experience - Near 45142
Summary Twenty-two years in the Medical Device Manufacturing Field, including 16 years of Director level experience in Quality Managements Systems, Regulatory Affairs and Quality Assurance/Quality Control Activities. Knowledge and professional experience in the following areas: Quality, Engineering and Manufacturing Implemented practical oversight of the following: * ISO13485 * ISO9001 * 21CFR820 (FDA) * ISO14971 Risk Manag...
Ideal Companies: A company with suability, growth and development of their employees.
Tags for this Online Resume: Audit, Engineering, Management, Management Review, Manufacturing, Medical, Quality, Quality Assurance, Quality Control, Regulatory Affairs, steel, medical device, medical devices, Quality Director, Director of Quality & Regulatory
Quality Manager - 20 Years of Experience - Near 33069
To secure a position in industry utilizing my technical and managerial skills. CAREER CAPSULE: Progressive experience in manufacturing, embracing Production and Quality Assurance. Skilled at directing all phases of manufacturing from Design, Pattern Making, Production, Quality, & Shipping. ISO Management 9001-2008 & 9001-2015. ISO 13485. Proactively managed large and small staffs in manufacturing operations. VAS AERO SERVIC...
Tags for this Online Resume: Management, Quality, Quality Assurance, Quality Management, Audit, Textiles, ISO, MAS 90, Payroll, Quick Books
System Operator - 14 Years of Experience - Near 92883
Professional Summary: A professional in Document Control with a background in Commercial and Aerospace Manufacturing. Responsible for organizing and handling of numerous documents in an office and Manufacturing environment. Qualifications * * 14 years in Document Control * Micro Office Word, Excel Outlook * SAP, Systems Applications, Production * MRP, Material Requirements Planning * SmarTeam, Engineering /Manufacturing pro...
Tags for this Online Resume: Process Control, Administrative Assistant, Document Control, Electronics, Microsoft, Microsoft Office, Microsoft Outlook, Program Manager, ISO, Audit
Electrical Engineer - 11 Years of Experience - Near 10930
Summary of qualifications Over 30 year's experience, this includes the following: * Instrumentation control system development and implementation. These include Process Control, PLC Programming, Water System, HVAC, Clean Room, Analytical instrumentation, Packaging Equipments, Waste treatment, Sterilizer, Compress Air and Steam Turbine Combined/Cogeration. * Write and execute test scripts Installation Qualification, Operatio...
Tags for this Online Resume: ISO, Instrumentation, Medical, Quality, Quality Assurance, Quality Control, Clean Room, Control Systems, Fabrication, Surgery
