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Online Resumes with "Iso 13485"



Director - 20 Years of Experience - Near 06804

Professional Summary 2016 to Present: MICRO SYSTEMS TECHNOLOGIES (Specialty Medical Components & Assembly) Regional Account Manager - Eastern US -Business Development and strategic account management focusing primarily on medical sector OEMS and high-performance applications including specialty PCB fabrication, custom IC/3D packaging, LTCC, primary-cell batteries, SMT Assembly/Test and Design Services. (ISO 13485) -Consult ...

Tags for this Online Resume: Business Development, New Business Development, Integrate, Manufacturing, NPI, Business Development Manager, Retail, CT, Management, Process Improvement, management

Director - 23 Years of Experience - Near 28079

Summary Ambitious Sr. Manager with more than 23 years of management experience in Manufacturing/Distribution/Logistics/Repair & Refurbishment environments. Applies strong analytical and critical thinking skills to solve complex operational problems. Ability to direct complex projects from concept to fully operational status, goal-oriented individual with strong leadership capabilities and a passion to succeed. Ability to st...

Tags for this Online Resume: Distribution, Process Improvements, Logistics, P&L, Configuration Management, Configure, IBM, Management, Services, Telecommunications

Featured Profile

President - 20 Years of Experience - Near 60068

Senior-level operations leader with 25+ years of experience spearheading improvement initiatives to enable rapid growth and dramatically increase revenue, boost market share, and drive brand recognition. An innovative thinker with a passion for achieving and exceeding goals, fostering team loyalty, and generating true company value — poised to join a firm that desires a leader with a philosophy of constant business improvem...

Ideal Companies: Manufacturing

Tags for this Online Resume: Logistics, Payroll, Benefits, Budgeting, Cash Flow, Human Resources, Insurance, Pricing, Recruiting, Sourcing, P&L LEADERSHIP, STRATEGIC PLANNING, PROFITABILITY OPTIMIZATION, MULTIMILLION-DOLLAR BUDGETING, TRAINING, COACHING & MENTORSHIP, CONTINUAL PROCESS IMPROVEMENT, PERFORMANCE MONITORING, RELATIONSHIP DEVELOPMENT, MULTISITE FACILITIES MANAGEMENT, PROCESS & POLICY IMPLEMENTATION, RESPONSIVE EMPLOYEE RELATIONS, HR/RECRUITING, REGULATORY COMPLIANCE, CONTRACT NEGOTIATIONS, MANUFACTURING & QUALITY MANAGEMENT, SUPPLY CHAIN OVERSIGHT, Productivity & Efficiency Gains, Turnaround Expertise, Process Improvement, Time & Resource Optimization, Expedited Growth, CHANGE MANAGEMENT, ISO - AS 9100, ISO 13485, ISO/TS 16949 & ISO 9001, Six Sigma, 5S methodology, TPS, lean manufacturing, visual management, performance measurement, Poka-Yoke, QCO, TPM, QCPC, Kaizen & Kanban., Private Equity, Portfolio Company, EBITDA Growth, Revenue Acceleration, Margin Enhancement, Multiple Expansion, Deal Origination, Topgrading, New Channels, New Markets, International Expansion, CEO, Global Footprint, CXO, COO, Turnarounds, Exit Strategies, President, Vice President, Director, Director of Manufacturing, Director of Operations, Vice President of Manufacturing, Vice President of Operations

Production Manager - 20 Years of Experience - Near 46582

Summary of Qualifications Material Management Production Planning Warehouse Operations Manufacturing ERP System Implementation Lean Manufacturing ISO 13485 Compliance Six Sigma P&L Responsibility Staff Training * Strong knowledge of and experience in leveraging Lean Manufacturing and the Theory of Constraints in driving business change and continuous improvement. * Proven record of restructuring operations and staff functio...

Tags for this Online Resume: Automotive, Consulting, Scheduler, Supply Chain, Inventory, Management, Scheduling, machine operator, die cutting, maintenance, electrical engineer, reliability, "project management", mechanical engineer, steel

Quality Coordinator - 5 Years of Experience - Near 08817

PROFESSIONAL PROFILE SUMMARY * A Quality professional with over twenty years' experience in Pharmaceutical and Biotechnology industries. Expertise in pharmaceutical, biological and aseptic manufacturing of sterile injectable and non sterile drug products with an emphasis on regulatory compliance including deviation review (laboratory and production), FDA inspection readiness, quality systems and cGMP compliance. Implemented...

Tags for this Online Resume: Management, Compliance, Reviews, Pharmaceutical, Audit, Documentation, Quality Assurance, Test, Manufacturing, manufacturing, production, reliability, mechanical engineer, electrical engineer, machine operator, maintenance, die cutting

Engineering Manager - 20 Years of Experience - Near 55378

Summary Over twenty (20) years' experience in product development and manufacturing of plastic molded components, assemblies, and finished devices for the Medical Device Industry. Strong background and experience in DMF, part design, mold design, and medical molding. Other key skills include: * * Engineering Management * Program Management * New Product Development * Class "A" Toolmaker and Mold Designer * Injection, Insert...

Ideal Companies: 3M, Colder Products, Entegris

Tags for this Online Resume: Product Design, Tool Maker, Tooling, Procurement, Manufacturing, MCAD Solidworks, Medical, Medical Devices, Product Development, Sales

Purchasing Agent - 20 Years of Experience - Near 80021

St Supply Chain professional seeking a position within a solid manufacturing company. Experienced in all aspects of Materials Management.

Tags for this Online Resume: ISO 9001, Logistics, NPI, Purchasing, ISO, Planning, Management, Inventory, Procurement, Project Management, manufacturing, "project management", production, Supply Chain, Cost Improvement

Quality Manager - 20 Years of Experience - Near 28314

PROFILE Quality Management professional with experience in Quality Engineering and Regulatory Compliance for Pharmaceutical, Medical Device, Automotive, and Aerospace products industry. Strengths include combining technical writing skills with business expertise to streamline processes while complying with domestic and international requirements. Results-oriented, consistently delivering high quality outcomes and recognized...

Tags for this Online Resume: Aerospace, Defense, Quality Assurance, Test, ISO, Audit, Automotive, Complaints, Compliance, Packaging

Life Scientist

SUMMARY: * More than 21 years of excellent experience in Medical Device & Pharmaceutical companies in the area of Process engineering, process Validations, Equipments Qualifications (IQ/OQ/PQ), Process Development Cleaning Validations, New Product Developments, Product and process Technology transfer, Troubleshooting Processes, and in Medical Devices, Product Testing. * Extensive experience in Quality assurances: Auditing, ...

Tags for this Online Resume: Risk Assessment, Quality, Corrective Actions, Process Improvement, Technology Transfer, Audit, Management, Training, Change Control, Good Manufacturing Practices

Life Scientist

SUMMARY: * More than 21 years of excellent experience in Medical Device & Pharmaceutical companies in the area of Process engineering, process Validations, Equipments Qualifications (IQ/OQ/PQ), Process Development Cleaning Validations, New Product Developments, Product and process Technology transfer, Troubleshooting Processes, and in Medical Devices, Product Testing. * Extensive experience in Quality assurances: Auditing, ...

Tags for this Online Resume: Risk Assessment, Quality, Corrective Actions, Process Improvement, Technology Transfer, Audit, Management, Training, Change Control, Good Manufacturing Practices

Mechanical Engineer

Summary: * Results-driven Manufacturing & Product Engineering Professional with a strong background in process development and validation, technology, product transfers, fixture design, development, and validation within highly regulated medical device environments including optical, opto-mechanical, and electro-mechanical systems and devices. * 10+ Years' Experience in writing validation/verification protocols and reports,...

Tags for this Online Resume: Manufacturing, Documentation, Purchasing, Test, Critical Care - Vascular, ISO, ISO 9000, LAPAROSCOPY, Product Development, Urology

Medical Transcriptionist

Areas of Expertise * Leveraging 510 (K) PMA and expertise in US, EU, TGA and Canadian medical device regulations. * Manage Kosher/Halal records for ingredients and resale products prepare kosher/Halal applications and registration for products and manufacturing facility. * Knowledge of U.S. FDA medical device regulations (21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807). * Knowledge of ISO 13485, ISO 14971, ISO 9001 and work...

Tags for this Online Resume: Manufacturing, Regulatory Affairs, Test, Advertising, Due Diligence, ISO, Quality Assurance, Compliance, Quality, Quality Control