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Online Resumes with "IQOQPQ"
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
Mechanical Engineer - 13 Years of Experience - Near 46037
To seek a position in a work environment that rewards performance while contributing to the growth and success of the organization. To obtain a position that will provide the ability to apply my management/leadership skills, communication and relationship skills, my ability to lead by example while mentoring employees and encourage individual growth, to meet project objectives and deliverables while maintaining a productive...
Tags for this Online Resume: plastic injection molding, Project Manager, Mechanical Engineering, SAP, Validation/Verification Testing, Project Leader, Manufacturing, GD&T, electronic packaging, IQ/OQ/PQ, Michigan, FDA, ERP, Supplier Relationship, RFQ, MS Project, DFMEA & PFMEA, Pro Engineer
Engineer - 20 Years of Experience
SUMMARY: Hands-on, Multidisciplinary Design Engineer with Project Management and NPI/NPD experience. Electrical, Mechanical, Electromechanical, Controls, Process, and Lean Manufacturing Systems Design, Development, Commissioning and Optimization. * Purpose Built Machinery Design, Development, and Automation for Manufacturing, Assembly, Packaging and Test. Design Specification to Installation and Commissioning, IQ/OQ/PQ (Pro...
Tags for this Online Resume: Electronics, Control Systems, Manufacturing, NEC, Power Distribution, Reliability, Troubleshooting, UL, IEC 60601, Systems Design
Biochemist - 18 Years of Experience - Near 21224
QUALIFICATIONS SUMMARY * cGMP quality management experience [ QA/QC and RA]. QA experience with quality management systems (QMS) and documentation, batch record reviews, annual product reviews, SOP drafting, review and approve, investigate deviation, change and document control. Established key performance indicators (KPIs), quality by design (QbD) process analytical technology (PAT) and Quality metrics. Experienced with de...
Tags for this Online Resume: Reviews, Chemistry, CMOS, Compliance, Documentation, Drafting, Product Development, Security, Systems Development, High Performance Liquid Chromatography (HPLC), pharmaceutical
Mechanical Engineer - 20 Years of Experience - Near 24502
SUMMARY Mechanical engineer with fourteen years of experience, launching 10 products from concept to commercialization. Mechanical engineer with 30 years of experience in the design of mechanical components and assemblies. Skills include prototype designs, in-depth experience with validation requirements (IQ/OQ/PQ), GD&T standards, ProE, Solidworks, Lean, Six Sigma, Green Belt DMAIC. High volume manufacturing, medical equip...
Tags for this Online Resume: GD&T, Security, Applications, Consulting, Satellite, Autocad, Autodesk AutoCAD, Fabrication, Microsoft Windows, Program Manager
Quality Engineer - 4 Years of Experience - Near 80918
Summary of experience Extensive experience in Medical Device Design, Development and Manufacturing Quality: New product Design experience: 10 new product design projects, and over 30 product redesign projects Design Input: VOC, Risk Analysis (HA & dFMEA), MRD, DRD Design Output: Verification & Validation testing (ex - & in-vivo, human factors & clinical) Mfg. Qualification experience: IQ/OQ/PQs, DOEs, MSAs, GR&Rs Six-Sigma ...
Tags for this Online Resume: Product Development, Reliability, Evaluate, Product Development, Quality Assurance, Reliability, MicroElectronics, Silicon Wafers, Test, DFMEA, Quality, Quality Engineering, Medical Device, Medical device product development, Continuous Improvement, Supplier Quality, project engineer, project manager
Electrical Engineer - 11 Years of Experience - Near 10930
Summary of qualifications Over 30 year's experience, this includes the following: * Instrumentation control system development and implementation. These include Process Control, PLC Programming, Water System, HVAC, Clean Room, Analytical instrumentation, Packaging Equipments, Waste treatment, Sterilizer, Compress Air and Steam Turbine Combined/Cogeration. * Write and execute test scripts Installation Qualification, Operatio...
Tags for this Online Resume: ISO, Instrumentation, Medical, Quality, Quality Assurance, Quality Control, Clean Room, Control Systems, Fabrication, Surgery
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
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
