CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "IQ OQ PQ"

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

Quality Manager - 20 Years of Experience

Summary Over 20 years' experience in a medical device industry. Out of the box thinker who is self-managed, self-motivated, results oriented, quality conscious, problem solver, with ability to multi-task, make decisions, resolve issues, meet deadlines learn new skills and communicate effectively at all levels of the business. Experienced in the following: Receiving Inspection, Final inspection, internal auditing and supplie...

Tags for this Online Resume: Quality, Quality Assurance, Quality Control, Angioplasty, Internal Auditor, Good Manufacturing Practices, Manufacturing, Project Coordinator, Test, Green Belt

Clinical Data Management - 1 Years of Experience - Near 02176

SUMMARY: 4 years of experience in working with both Sponsor and CRO industry focusing on computer systems validation, query management and clinical data management documentation. Worked on creating and handling validation master plan, data management plan, case report forms, change control and data validation specifications. Experience in validation of software's of clinical trial databases, ePRO-electronic patient reported...

Tags for this Online Resume: Documentation, CFR Part 11, Management, Test, Test Scripts, Data Management, Hematology, User Acceptance Testing, Acceptance Testing, Change Control

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

Manager - 15 Years of Experience - Near 64146

Tags for this Online Resume: CSV, IQ OQ PQ, Validation, FDA, DataCenter

Quality Supervisor - 18 Years of Experience - Near 11434

SUMMARY A professional Quality Control and Quality Assurance Engineer/Specialist with 9 years of experience implementing and improving quality management systems/ programs to support Manufacturing, instrumentation, Validation, and processes Quality Management Systems and Information Management Systems Qualification Summary: Quality Assurance (manufacturing) * Experienced in ISO 9001 and ISO 13485 standards to ensure that pr...

Tags for this Online Resume: Quality Assurance, Test, Database, ISO, Management, Manufacturing, Procurement, Quality, Quality Control, Quality Management, manufacturing, production

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

General - 13 Years of Experience - Near 10701

Summary of Qualifications Enthusiastic, self-starter with the ability to present products/ideas persuasively and build rapport. Flexible, multi-tasker with a strong work ethic and ethics and character of the highest caliber. Creative, attentive to the completion of precise tasks and projects. Enjoys taking initiative beyond stated job and is sensitive to needs of others. Qualified professional providing expertise in the lab...

Tags for this Online Resume: Technical Writer, Quality Assurance, Regulatory Affairs, Research, Compliance, Manufacturing, Quality, Quality Control, Documentation, Reliability, Research and Development, Document Control, HIV

Quality Professional

Qualifications Skills: Regulatory Affairs/quality assurance: Projects, related skills and practice include: * Prepare and submit 510 (k) s for US FDA on Class I and Class II Medical Devices and assisted with the preparation of Class III submittals * Compile, document and submit Technical Files for Europe (CE Marking) per Medical Device Directive (MDD) * Perform monthly trending analysis * Developing quality systems plan inc...

Tags for this Online Resume: Manufacturing, Medical, Medical Devices, Risk Analysis, Documentation, Failure Analysis, ISO, Quality Assurance, Quality, Statistical Analysis

Microbiologist - 20 Years of Experience - Near 07753

Summary I am a Scientist with twenty nine years of professional experience in the pharmaceutical, medical device, clinical and biotech industries. I have written SOPs, CAPA, audit reports, validation master plans, protocols, new product submissions and various other technical documents. I am very familiar with QSR, 21CFR211 and ISO standards: 13485, 14644 part 1 and part 2. I have used the five "whys" and fishbone methods f...

Tags for this Online Resume: Data Entry, Documentation, Root Cause Analysis, Technical Writing, Packaging, ISO, Pharmaceutical, Statistical Analysis, Audit, Management, pharmaceutical, sap