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Online Resumes with "13485"



Product Safety Engineer

SUMMARY: Multidisciplined Electrical Engineering background with wide experience in Product Safety and EMC/EMI compliance procedures and tests Design, Research, Testing, System development, integration and implementation, Product and Quality Systems Certification ( ISO 9001/9002, ISO17025, ISO 13485), analysis and considerations of corrective and preventative actions (CAPA) for Electrical, RF, Telecommunications and Medical...

Ideal Companies: REgulatory Compliance Electrical Engineer (Product safety and EMC/EMI compliance

Tags for this Online Resume: Electronics, Research, Siemens, Systems Analysis, Xerox, Integrate, Quality, Test, IEEE, ISO

Masters in Biomedical Engineer, Irvine

Tags for this Online Resume: quality control, ISO 13485 -2003, biomedical engineer, thermoplastics, medical devices, materials engineer, thermo plastics, autocad, polymer processing, metals, injection molding, regulatory compliance, solidworks, solidworks

Director of Quality

CAREER SUMMARY Ethical, strategic, and transformational leader who engages teams to deliver business results and drive sustainable excellence. Engineering Professional/Lean Six Sigma Black Belt with over 20 years + of experience in Quality, Supplier Quality, Process Engineering, and Kaizen/Lean Manufacturing in Food MFG/HACCP., Good Manufacturing Practices (GMPs), Vertical Pump Application, Global Drive Systems, elevators, ...

Tags for this Online Resume: Process Control, ISO, Management, SPC, Black belt, Layout, Policies and Procedures, Project Management, Project Manager, Quality

Director of Quality

Summary Dedicated professional with 20+ years' experience in Integrated Management Systems, including Quality (ISO 9001), Environmental (ISO 14001), and Health & Safety (OHSAS 18001) with 12+ of those years as Head of Quality Management in different industries. Broad experience in MS-Office, MS-Visio, Project Management (MS-Project) and SAP, cGMP, FDA 21 CFR part 820, ISO 13485, ISO / IATF 16949, IRIS, Supplier Management a...

Tags for this Online Resume: R&R Report Writer, Automotive, Management, Quality, Quality Assurance, Quality Management, ISO, ISO 9001, Documentation, Project Management

Operations Manager

Qualifications Profile Lean Green Belt certified professional with career-long expertise in manufacturing operations encompassing quality assurance, project and program management, budget control and allocation, new product development, and strategic planning. Drive operational productivity by integrating Lean principles and leading top-performing teams. Demonstrate adeptness at mentoring and motivating staff and personnel ...

Tags for this Online Resume: Manufacturing, Corrective Actions, Distribution, Electrophoresis, Engineering, Forecasting, Green Belt, Integrate, Inventory, Leadership

Quality Engineer - 17 Years of Experience - Near 76210

Apply my Education. Experience and Skill Set to either Quality/Supplier Quality/Supply Chain Management or Project/Program Management.

Tags for this Online Resume: Engineering, Purchasing, Corrective Actions, Management, Quality, Quality Assurance, Transmissions, Audit, Automotive, Medical Device, Consumer Goods, Supplier Management, Automotive Industry, Tooling Design, ISO 9000, TS 16949, ISO 14000, ISO 13485, Root Cause Analysis-5 Why, Fishbone, SPC, PPAP, APQP, Control Plans, Work instructions, Flow Charts, PSW, Quality Inspection

Production Supervisor

Summary Manufacturing Professional - Solid experience directing and supporting multi-shift, cGMP/QSR production operations for medical device product lines in an FDA registered facility. Managed team of 60 employees and 3 supervisors. Responsible for compliance with FDA 21 CFR Part 820 and ISO13485 regulations. Character - a strong work ethic of integrity and honesty with perfect attendance Additional Qualifications High pu...

Tags for this Online Resume: manufacturing, reliability, production, Lean Manufacturing, Packaging, Disaster Recovery, Inventory, Sales, Allergy, Pharmaceutical

Quality Manager

MAJOR ACCOMPLISHMENTS: * Instrumental in increasing approximately $3 Million in revenues in the first year by developing and implementing a novel UV curing process to terminate stimulating hydro-gel used in the manufacture of neuro stimulating and sensing electrodes. * Saved approximately $2 Million in the first year by eliminating scrap, returned devices, customer complaints, legal suits and consulting fees by changing and...

Tags for this Online Resume: Documentation, Manufacturing, Quality, Quality Assurance, Quality Control, Complaints, Test, Audit, Fraud, Health Insurance

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