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Online Resumes with "IQ OQ"
Engineer
SUMMARY: Proven engineering expert with broad global experience in medical device, drug delivery, automotive, and aerospace engineering. Served roles in R&D, Product Development, Manufacturing, Quality, Validation, & Supplier Quality Engineer. Six Sigma Greenbelt. Broad domestic and global Manufacturing & Quality Engineering experience at locations in: US: Utah, Michigan, Ohio, Indiana, Wisconsin, Minnesota, New York, & Mas...
Tags for this Online Resume: Product Development, Quality, Quality Assurance, Research and Development, Six Sigma Greenbelt, Six Sigma Quality, Aerospace, Automotive, Engineering, Global Experience, DOE, IQ/OQ/PQ, FMEA, GR&R, MSA, ISO 13485, 21 CFR 820, Process Validaiton, CNC Machining, CMM Programmer, FAI, Molding, Extrusion, CAD, Toyota Production Systems, Lean Manufacturing, Medical Device, Clean Room Validation
Director of Quality
Tags for this Online Resume: Corrective Actions, Management, Quality, Quality Assurance, Quality Management, Budgetary, Financial, Financial Services, Services, Manufacturing Engineer, Mechanical Engineer, CAPA, Process Development, Innovation, Medical Device, Regulatory, ISO, Molding, Automation, Design, Life Sciences, MRB, Strategic, IQ OQ PQ, TQM, 5S, 6 Sigma
Production Supervisor
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, Audit, Corrective Actions, Management, Process Improvement, Technology Transfer, Training, Change Control, Good Manufacturing Practices
Quality Assurance Director - 13 Years of Experience - Near 60453
SUMMARY * 17 years of experience in pharmaceutical, Medical Devices, and FDA regulated environment including Quality Assurance and Process Computer System Validation. * Experience in generating all validation documents, including Validation Plan (MVP), Gap Analysis, Design Specifications, IQ, OQ, and PQ Test Protocols, Standard Operating Procedures (SOPs), and Validation Summary Reports. * Experience in Manufacturing Proces...
Tags for this Online Resume: Compliance, Manufacturing, ISO, Filing, Management, MDR, Process Improvement, Quality, Quality Assurance, Quality Management
Not Listed - 20 Years of Experience - Near 07936
SUMMARY I have a Quality Assurance background (various areas of QA) with experience managing and overseeing QA processes in a Pharmaceutical and Medical Device regulated environment. Produce statistical documentation and communicate with senior-level managers regarding Quality Assurance/Training issues. Provide supervision and training to QA group members. Sustain quality and compliance levels. I am skilled in the following...
Tags for this Online Resume: Manufacturing, Test, Management, Audit, Validation, Database, Documentation, Microsoft Office, Quality, Quality Assurance, Investigations, Microbiologist
Not Listed - 20 Years of Experience - Near 94704
Professional Profile Pg 3 of 3 Hanan Altschuler, Machine Builder/Technologist - Process / Mechatronics Engineer P. O. Box 265, Berkeley, CA 94701 Forensics / Productivity and Quality / Validation E-mail: hanan@lmi.net Other Specialized Experience: * Use of multi-disciplinary approach to design products incorporating optical, mechanical, electrical, chemical, biological, and other technologies in a single product with compli...
Tags for this Online Resume: ANSI, quality, Automation, Automotive, CNC, Compliance, DFS, Documentation, Engineering, Failure Analysis, R&D, industrial design
Industrial Engineer
Qualifications of a Senior Industrial Engineer/ Project Engineer Dynamic results-oriented Senior Industrial Engineer with experience in product launch, pharmaceutical regulations, project management and development and execution of projects. Decision maker capable of making analytical judgments to drive the attainment of growth objectives through leadership and solving problem skills. Highly motivated by challenges and dedi...
Tags for this Online Resume: Management, Documentation, Manufacturing, Business Plan, Compaq Alpha, Corrective Actions, English Language, Good Manufacturing Practices, HR, Human Resources
Director
SUMMARY OF QUALIFICATION * Extensive experience in FDA regulatory requirements (GMP, CFR) and ISO standard regarding Medical Device, Pharmaceutical, Skin Care, and Food Industry * Extensive experience Lean Quality Tools (FMEA, Pareto Charts, Fishbone Diagrams, Six Sigma 5S, and SPC to assure efficient process and high product quality product * Extensive experience in managing the Supplier/ Vendor qualification program, Supp...
Tags for this Online Resume: Extensive experience in CAPA, Extensive experience in IQ/OQ/PQ VAlidation, Extensive experience Quality audit, Extensive experience Supplier Qualification, Extensive experience FDA and ISO Regulatory, Extensive experience Process and Quality improvement, Extensive experience Reducing customer complaint, Scheduling, Chemistry, 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
Program/Project Manager
Highly skilled innovated mechanical engineer with proven track record of achievement in design, manufacturing, project and program management experience with international Fortune 500 companies. Pragmatic Manager who specializing in driving companies to capture, growth and sustain profitably and market share. Provides vision and strategies to transforms corporate initiatives and projects to lucrative realities Expert in mec...
Ideal Companies: General Atomics, illumina, Sony
Tags for this Online Resume: LeanManufacturing, Project Management, Quality Assurance, Technology Transfer, Consumer Electronics, Biomedical, GD&T, Process Improvement, Mechanical Design, SolidWorks, Program Management, New Product Introduction, Manufacturing Engineering
Business Analyst
SUMMARY Over 6 years of experience as a Business Systems Analyst in Pharmaceutical and Medical Devices industries with comprehensive understanding of GxP Regulations. Good understanding of various System Life Cycle models, Waterfall and Agile methodologies. Participated in all phases from analysis, design, and development through testing, implementation and change control. Experienced and proven ability acting as liaison be...
Tags for this Online Resume: ACD, Applications, Asset Liability Management, Asset Management, Automatic Call Distribution, Benefits, Business Analysis, Business Analyst, Business Requirements, CFR Part 11
Quality Assurance Specialist - 15 Years of Experience
AREAS OF EXPERTISE: * Over 12 years of experience in Computer System Validation (CSV)/Quality Assurance in the Pharmaceutical and Biotech industries including specialization in 21 CFR Part 11 Compliance. * Experience in Computer System Validation including Compliance Assessments, Validation Plans, User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Design Specifications (DS), Validation proto...
Tags for this Online Resume: Compliance, Test, Test Cases, Automation, Documentation, Protocol, Risk Assessment, Business Requirements, SAS, Test Plan
