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Online Resumes with "13485"
Risk Management - 19 Years of Experience - Near 01845
FAMILIARITY WITH: ISO 1009, ISO 10993, ISO 13485, ISO 14969, ISO 14971, ISO 24971, 21 CFR Part 11, 21 CFR Part 820, IEC 62355-1, and HIPPA.
Tags for this Online Resume: Test, Test Plans, Quality, Unix, C++ Programming Language, C/C++ Programming Languages, Java Programming Language, Management, Quality Assurance, Software
Not Listed - 15 Years of Experience - Near 53221
tomygunz10@gmail.com Brewer Company is a manufacturer of high quality sewn and upholstered furniture supplied to the medical, dental, ophthalmology, pedicure, and nautical industries. Brewer Company is ISO13485 registered. * Project engineer for the OEM division responsible for estimating, designing, process planning, and pilot running projects in each of the industries listed above. * Pioneered the implementation of the se...
Tags for this Online Resume: Project Engineer, Lean Principles, Furnishings, ISO, Machining Center, Manufacturing, MRP, Plating
Department Manager - 20 Years of Experience - Near 92128
Areas of Expertise * Business Process Improvement * Environmental Monitoring * Inventory Control & Management * Production Planning & Scheduling * Strategic Planning & Implementation * Process Design & Validation * GMP and ISO 13485 Compliance Recruited to establish Production Reva Medical San Diego, CA Established and directed formal operations functions supporting production of pre-clinical and clinical supplies collabore...
Tags for this Online Resume: Automation, Hazardous Waste, Instrumentation, Integrate, Metrics, Order Processing, Process Improvement, Production Metrics, Management, Good Manufacturing Practices
Department Manager - 3 Years of Experience - Near 13485
SUMMARY Management / Leadership: Lead diverse teams consisting of Engineering, Production, Design and Raw Materials personnel, organized support functions such as Warehousing, Sourcing, QA/QC, Planning and Maintenance, drove superior results through continuous process improvement and leveraged technological innovations. Direct supervision of up to 25 people in 24/7 production environment. Extensive experience as a Project M...
Tags for this Online Resume: Project Management, Project Manager, Pharmaceutical, Process Improvements, Reliability, Management, Applications, Fabrication, Risk Assessment, Manufacturing, Validation, Food & Beverage, Chemical Engineer, Fermentation, Extraction, Distillation, Continuous Improvement, Cell Culture
Quality Engineer - 10 Years of Experience - Near 00782
PROFESSIONAL SUMMARY QUALIFICATIONS ASQ member, CAPA Expert Certified, CQA, Quality Risk Management - FMEA, Introduction and Internal Auditor for ISO 9001. Knowledge in cGMP Regulations and International Standard (ISO) as 21CFR820, ISO 13485, 21CFR210 & 211, ISO 9001 & ISO 14001. OSHA Rules, Quality Assurance & Control, Manufacturing, Production, Warehouse, Pest Control. Computer skills: Trackwise, SAP, Maximo, LIMS, Visio,...
Tags for this Online Resume: Manufacturing, Documentation, Quality Assurance, CAPA, Audit, Complaints, Investigations, Good Manufacturing Practices, Internal audit, Management, Systems
Clinical Regulatory Affairs - 20 Years of Experience - Near 53143
Summary 30 plus years in the Medical Device and Pharmaceutical industry. Extensive expertise in Supply Chain, Customs Compliance (import and export), Test methods and Process Validations, Technical product development and support, GTIN and UDID process for organizations that meet GS1 standards. Experience in Customs Compliance and Quality Systems Regulations as well as domestic and international standards. Core competencies...
Tags for this Online Resume: Customs Compliance, Scrum Master, Regulatory Affairs, Validation, HR, Quality, Compliance, Hepatitis, Planning, Quality Assurance, Project Manager, Medical devices
Medical Scientist
SUMMARY: * 30 years of experience with diverse range of technical and management experience in the drug, cosmetic and medical device business. * Experienced in leading and managing Six Sigma/Lean process improvement projects. * Use of high level business process mapping to diagnose gaps and find opportunities for process improvement. * Strong background in product formulation and reverse engineering techniques. * Experience...
Tags for this Online Resume: Wound Care, 5S, Kanban, Manufacturing, Medical, Medical Devices, MRP, Pricing, Sourcing, Supply Chain
Production Manager
SUMMARY Operations professional (BSIE) with over twenty (20) years of practical experience. Managed all operations including manufacturing / production, supply chain (warehouse / distribution, purchasing and inventory control), plant layout, quality, equipment maintenance / facility maintenance. Experience has led to knowledge of ISO 9001 /13485 initiatives lean implementation 5S, quality / safety initiatives JIT production...
Tags for this Online Resume: 5S, Manufacturing, Production Schedule, Quality, Quality Assurance, TQM (Total Quality Management), Bilingual, Distribution, Documentation, Employee Performance
Quality Engineer - 10 Years of Experience - Near 95127
SUMMARY Career highlights include building and directing a QA/QC function, Analysis, Testing, SPC project, Internal auditor in PWB high tech industry and Rechargeable Batteries of new technology (10+ years), Testing/Diagnose network systems to board level (5+years) & managing Analytical Labs in Food industry and Water Supply Sources (10+ years). Influenced on key committees and entrusted to manage the most confidential and ...
Tags for this Online Resume: Experience Auditor, Management experience, QA/QC profesional, Internal audit teamplayer, Microsoft Access profesional, Cisco system testing, Data Analysis Expert, Microsoft Excel professional, Microsoft Office profesional, NCR
Manager - 20 Years of Experience - Near 01037
Summary Enthusiastic practitioner of business development/planning principals $11MM budget with income statement and P/L accountability Project oriented and Lean tools practitioner i.e. SMED, Kaizen, 5S, VSM, Standard work etc Strong interpersonal skills, experienced with direct key customer/supplier interface Direct ISO 13485 - ISO 9001 implementation and compliance Supply Chain management for customers such as Smith and N...
Tags for this Online Resume: Value Stream Mapping, Distribution, ISO, ISO 9001, Management, Material Management, Scheduling, Buying, Plastics, Protocol, manufacturing, lean, 6Sigma
Plant Manager - 10 Years of Experience - Near 60564
Qualifications Profile Results-driven and goal-oriented professional with broad-based experience in industrial engineering, employee relations, quality and operations, product development, and project management. Skilled at establishing and managing contract manufacturers around the globe, while leading its development and ensuring organizational success. Equipped with exceptional ability to build and cultivate professional...
Tags for this Online Resume: Audit, ISO, Manufacturing, Quality, Quality Assurance, Data Analysis, Internal audit, ISO 9001, Process Improvements, Product Development
Quality Manager - 17 Years of Experience - Near 60051
SUMMARY OF QUALIFICATIONS * Certified Master Black Belt able to lead and influence people at all levels within a Manufacturing organization. * Proficient in the DMAIC Six Sigma and DMAIC/PDCA Lean Roadmaps, including many different lean and statistical methods such as: Value Stream Mapping, 5S, Visual Management, Quick Changeover, Kaizen Events, Problem Solving, Mistake Proofing, Gap Analysis, Standard Work, Process Map, C&...
Tags for this Online Resume: Software, 5S, Complaints, Documentation, ISO, Product Development, Systems Analysis, Black belt, Kaizen, Management
