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Online Resumes with "IQ OQ"
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 and SAP, cGMP, FDA 21 CFR part 820, ISO 13485, ISO / IATF 16949, IRIS, supplier management and all aspects...
Tags for this Online Resume: R&R Report Writer, Automotive, Management, Quality, Quality Assurance, Quality Management, ISO, ISO 9001, Documentation, Project Management
Program Manager - 0 Years of Experience
Career Summary * Over a decade of experience as a Project Manager, primarily in the medical device industry, and inclusive of the following professional skills: * Project Management and New Product Development * Product Design & Engineering (for manufacturability, DFM) and Engineering Change Control * GMP, Good Manufacturing Practice, and Lean Six Sigma Manufacturing * Process Development and Statistical Process Control * I...
Tags for this Online Resume: Training, Billing, Change Control, Compliance, Documentation, Engineering, Management, Medical, Medical Devices, Process Control, manager, civil engineering, architecture, construction management
Quality Engineer - 20 Years of Experience - Near 06514
Summary * A skilled, accomplished and hands-on Mechanical Engineer with over 30 years of experience in Manufacturing and Quality Assurance / Control. * Adept in English and Metric Systems of Measurement. * An in-depth knowledge and background in Geometric Dimensioning and Tolerancing, applied to engineering documentation developed in "First" and "Third" Angle Projection Systems. * Solid professional knowledge and experience...
Tags for this Online Resume: CMM (Capability Maturity Model), Automotive, Manufacturing, Quality, Quality Assurance, Quality Control, Aerospace, Instrumentation, R&R Report Writer, Test
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
Director of Quality - 20 Years of Experience - Near 91709
SUMMARY OF QUALIFICATIONS * Over twenty years of experience managing regulatory affairs (RA)/quality assurance (QA), quality control (QC)/research & development (R&D) departments in pharmaceutical, medical device and dietary supplement manufacturing industries. Implemented Quality Management Systems meeting domestic and international regulatory requirements and ISO registration. Reviewed pre-clinical, clinical and pharmacok...
Ideal Companies: Pharmaceutical, Medical Device, Biomedical
Tags for this Online Resume: Quality, Quality Assurance, Quality Control, Manufacturing, Regulatory Affairs, Microbiological Testing, Test, ISO, Pharmaceutical, ADA
Plastics Engineer
SUMMARY Quality Engineering professional with 30+ years of experience driving process improvements and defect elimination in the automotive, aerospace, injection/blow molding, aluminum extrusion, medical, and commercial manufacturing sectors. Internal and Supplier Continuous Improvement, Tooling Evaluation, Aftermarket Production Systems, VDA 6.3 Certified Auditor, Trainer/ Facilitator TS16949, ISO 9001 - 2015, PFMEA, CP, P...
Tags for this Online Resume: Documentation, PPAP, Quality, Quality Assurance, Tooling, PFMEA, Facilitator, ISO, Management, Quality Management
Engineering Manager - 6 years Experience, Engineering - 20 Years experience, Quality - 6 Years
SUMMARY Follows a defined process of management that consistently incorporates the voice of the customer and manufacturability within the limits of sustainable process controls. Products and processes have had higher gross margins and inherently shorter lead times than original objectives. Technically adept and intuitively leverages experience against available resources to deliver exceptional support and resolve critical i...
Tags for this Online Resume: Critical Care, Engineering, Failure Analysis, Integrate, Manufacturing, Manufacturing Engineering, Product Development, Project Management, Project Manager, Reliability, Quality, AS9100, ISO-9001, NADCAP, FDA, GMP, Aerospace, Medical, Patent, FMEA, LEAN, R&D, Operations, Budgets, Standards, Compliance, Validation, Verification, Testing, DO-160, UL, CSA, IEC, JSTD, Root Cause, Corrective Actions, Bio Pharma, Robotics, Automation, Industrial, Commercial, Manager, Sikorsky, Lockheed Martin, Boeing, 5S, MRB, SPC, IQ-OQ-PQ, Tooling, Value Added Engineering, Eraned Value Management, ROI, Profitability, DOE, Scheduling, Marketing, Trainer, SOP, QMS Author, FAIR, Life Sciences, Project Engineer, Senior Engineer, Microfluidics, HMI, PLC, Qualification, Source Inspection, Audits, Supplier Management, Obsolescence Program
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
Quality Engineer
Summary of Qualifications Manufacturing engineering, experienced in both Research and Development (R&D) and operations. Generated Protocols and reports documenting validation of manufacturing equipment and processes to satisfy both FDA and CE requirements (e.g., IQ, OQ, PQ, ). Participated on a R&D team that brought new products to market from concept to finished goods. Conceptualized automation of a syringe manufacturing l...
Tags for this Online Resume: Evaluate, Manufacturing, TIP, Automation, Engineering, ISO, Lean Manufacturing, Manufacturing Engineering, Microsoft Windows CE, Research
Department Manager - 20 Years of Experience - Near 00693
Professional validation expert and scientist with up to thirty years of overall experience in the Pharmaceutical Medical Device and Biotechnology Industry. Proficient in manufacturing industry environment including but not limited to facilities utilities solid dosage equipment HVAC water systems chemical plant equipment chemical biotechnology and microbiology instrumentation handling validation (IQ OQ PQ) validation plans c...
Tags for this Online Resume: Quality, Quality Assurance, Project Leader, Project Management, Support, Manufacturing, Test, High Performance Liquid Chromatography (HPLC), Injection Molding, Instrumentation
