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Online Resumes with "oq"
Life Scientist - 20 Years of Experience - Near 02642
SUMMARY IT/QA PROFESSIONAL Biotech - Pharmaceutical - Medical Device - Life Sciences Highly skilled consultant and Project Manager with diversified domestic and international experience and a background that incorporates strong technical orientation with business skills. Hold proven record of success in product development, process improvement, cGMP compliance, validation and quality control. Examples: * Software Implementa...
Tags for this Online Resume: Software, Compliance, HVAC, Management, Support, Assessments, Automation, Integrate, Manufacturing, Millenium (Sw-Fin/Admin), gcp, pharmaceutical, sas, protocol, clinical
Mechanical Product development / manufacturing Engineer - 20 Years of Experience - Near 06443
Professional Summary Experienced Manufacturing Engineer with Production Management and Product Development Engineering Experience. Started career in product development where I managed projects and cross functional teams eventually being promoted into engineering management. Later, as production manager, I managed a 30 million dollar manufacturing department and was responsible for maintaining all KPI's and providing engine...
Tags for this Online Resume: Manufacturing, Construction, Engineering, Enterprise Requirements Planning, Green Belt, Injection Molding, Kaizen, Layout, Lean Manufacturing, Management, project engineer, project manager, mechanical engineering, SOLIDWORKS, Medical Device, OQ IQ PQ, validation, product development, Tooling design, Fixture design, manager
In Between - 15 Years of Experience - Near 27572
QUALIFICATION SUMMARY Thirty-five years of pharmaceutical/biotech industry biotech with management experience. Able to adapt to rapidly changing business situations and move forward with change while using strong communication skills to facilitate a high level of collaboration among peers and co-workers. Broad background of experience and expertise in the following areas: * Quality Control/Quality Assurance * Team Developme...
Tags for this Online Resume: Training, Corrective Actions, Data Processing, Good Manufacturing Practices, Manufacturing, Quality Assurance, Test, Data Entry, Document Management, Filing
Quality Coordinator
SUMMARY Quality Assurance Manager with expertise in pharmaceutical and chemical, quality control and quality assurance areas. Managing and coordinating quality assurance functions of pharmaceutical and chemical industry from inception to completion while communicating horizontally and vertically in a highly regulated FDA/EU environment. Possess a background in both Fortune 500, entrepreneurial and start-up environments. Exp...
Tags for this Online Resume: Complaints, Quality, Quality Assurance, Quality Control, Compliance, Test, Audit, Corrective Actions, DSC, High Performance Liquid Chromatography (HPLC), rn
Production Manager - 20 Years of Experience - Near 32825
PROFILE A strategic results-driven Quality / Validation, Operations, Engineering, and Project Management Professional with more than 15 years of experience in world class Pharmaceuticals and Medical Device industries. Vast experience compliance of cGMPs and associated regulations, investigations and corrective actions (NC & CAPA), remediation's planning/budgeting and execution of commitments to FDA, equipment and facilities...
Tags for this Online Resume: Quality Assurance, Budgeting, Complaints, Compliance, Consulting, Corrective Actions, CVS, Distribution, Engineering, Management
Quality Manager - 20 Years of Experience - Near 37064
Manager - Accountable for all aspects of ISO 9001:2008 quality management system and quality control. * Lead a staff of 8 quality professionals provided unprecedented level of service to both internal and external customers. * Developed formal validation and design procedures for medical device components compliant to cGMP. * Led all CAPA (RCCA) efforts. Enhanced successful closure by 70% and strengthened root-causes and tr...
Tags for this Online Resume: Science, Acceptance Testing, Protocol, Quality, Quality Assurance, Test, Manufacturing, Corrective Actions
Mechanical Engineer - 1 Years of Experience - Near 48034
Summary: An ambitious engineer with 6 years of educational background over mechanical engineer which includes diverse knowledge over design, thermal engineering, HVAC and fracture mechanics and also experience as Mechanical Engineer Intern at a major bearing manufacturing company. Intermediate knowledge on Validation Engineering and the concepts related to such as IQ, OQ, PQ and other computer system validation deliverables...
Tags for this Online Resume: ANSYS, ASME, Autocad, Autodesk AutoCAD, CAD Tools, CNC, Engineering, Fabrication, HVAC, IBM CATIA, design engineering
Industrial Engineer - 15 Years of Experience - Near 06422
SUMMARY An analytical, results-driven quality management professional with extensive experience leading quality in Medical Devices, Biologics, Combination products, Pharmaceuticals, 510K and 503B Human drug compounding. Hands-on experience in new product development, design for six sigma, validations (IQ, OQ and PQ), risk management, complaints/post market surveillance, CAPA, auditing, supplier management, cGMP/GLP, as well...
Tags for this Online Resume: Quality Assurance, R&R Report Writer, Test, Quality, Assessments, Complaints, Troubleshooting, ISO, Medical, Medical Devices, Quality ASssurance, Medical Device, ISO, 503B, Complaints, Design Control, Quality,
Process Engineer - 15 Years of Experience - Near 55376
To benefit an organization that can use a knowledgeable Six-Sigma Black Belt Quality Manager with a proven ability to continuously improve processes/customer satisfaction and supplier development while building a strong project team, and strengthen customer relation using various Six-Sigma/Project Management tools and methodologies. Responsibilities: ISO 13485, 14971 Managing/Directing quality staff. Supervising/ Mentoring ...
Tags for this Online Resume: Audit, Data Analysis, CMM (Capability Maturity Model), Management, Product Development, Reliability, Stents, Heat Treating, Plastics, Msa (Accounting Pkg)
validation/quality/manufacturing engineer
PROFESSIONAL SUMMARY: * Experienced as validation engineer and experience in Process Validation, and Test Method Validation in compliance with FDA standards * Expertise in writing Test method Validation Protocols (TMV-P) and executing the protocols * Experienced in validating different types of test methods (Attribute Test Method, Variable Destructive Test Method, Variable Non-Destructive Test Method, Analytical Test Method...
Tags for this Online Resume: Reviews, Root Cause Analysis, Test, Assessments, Documentation, PFMEA, R&R Report Writer, Regulatory Affairs, Reliability, Risk Assessment, manufacturing
PROJECT MANAGER
Career Summary * Over a decade of experience with medical device manufacturing, inclusive of the following: * Project Management, specifically New Product Development * Design Engineering and Control * Manufacturing Engineering and Six Sigma Manufacturing * Process Development and Statistical Process Control * Quality Management, Testing, and IQ/OQ/PQ Validation * Regulatory Compliance and GMP (FDA Class I, II, and III devi...
Tags for this Online Resume: Billing, Compliance, Documentation, Engineering, Management, Medical, Medical Devices, Process Control, Program Manager, Quality, PROJECT MANAGER, PROJECT ENGINEER, MANUFACTURING ENGINEER, MEDICAL DEVICE MANUFACTURING, REGULATORY COMPLIANCE, DESIGN & DOCUMENTATION, OPERATION MANAGEMENT, SALES & MARKETING
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
