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Manufacturing/Process Engineer and Product/Process Develoment

Manufacturing & Production Resumes - Aircraft Rigging Assembler Resumes - Wake Forest, NC

Hi: It’s my interest be part of a good company in Durham/Raleigh area and makes available my abilities, knowledge in the Mechanical Engineering and experience in Projects Management. I have experience in the Process and Manufacturing Engineering area. In the past I lead a small Product Development group and supports new product developments by managing the prototype hardware builds process, providing timely product and...

Senior Quality Assurance / Labeling (Regulatory Compliance) Manager

Science & Biotech Resumes - Clinical Regulatory Affairs Resumes - Menlo Park, CA

I'm an Senior Manager / Director level professional with 17+ years' experience in medical device labeling, regulatory compliance, risk analysis, quality systems/CAPA, and process engineering. I regularly am enrolled in classes at Stanford University and enjoy other forms of professional development; see my profile at www.linkedin.com/in/aimeecampbell

Tags for this Online Resume: labeling, quality, FDA, CAPA, device, process engineering, translation, MDD, Health Canada, Menlo Park, SF Peninsula, San Francisco, manager, project, EU, DMR, Risk, DHF, analysis, implementation, operations, Director, team, leader

manufacture engineer- 12 years, quality engineer - 5 years

Engineering & Architecture Resumes - Process Engineer Resumes - Morgan Hill, CA

• More than 15 years of engineering experience in Manufacturing & Quality Eng. dealing with computers, semiconductor, Class I & II medical devices, process & product development. • Provided documents for Build Tree, Process Flow, DMR, DHR, SOP, MPI’s for medical and electro mechanical devices using MS Word, MS Visio, Solid Works, and Adobe Photo Shop. • Qualified in using hand & power tools & electronic test equipment (e.g....

Chemical Engineer/Biomedical Engineer - 8 Years of Experience - Near 60629

Engineering & Architecture Resumes - Chemical Engineer Resumes - Chicago, IL

Objective: To serve the medical device community as a technical leader in new product development and continuous product improvement. Innovative Research & Development Engineer with experience designing, implementing, and testing medical devices for fluid management and processing. Technical leader and contributor on cross-functional teams in new product development, risk management, product testing, and DHF remediation/Reg...

Tags for this Online Resume: Innovative, new product development, technical leader, feasibility, root cause analysis, verification, design, method development

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Scientific Project Management - Medical Device Development

Science & Biotech Resumes - Biologist Resumes - Round Lake, IL

My expertise & experience is in medical device design and development, from disposable catheters & ostomy products to more complex wound dressings & tube securement devices for critical care/ICU applications as well as in-vitro diagnostics (IVD's). I am most interested in senior level scientific or technical project manager positions (non-IT related). I am a passionate, "hands-on" team leader, accustomed to a dynamic smal...

Ideal Companies: Abbott, Baxter, Becton Dickinson, Biomerieux, BSN Medical, Boston Scientific, Coloplast, Covidien, C.R. Bard, Edwards Life Sciences, Fresenius Kabi, GE Healthcare, Gore Medical, Integra Life Sciences, Medline, Medtronic, Stryker, SynCardia Systems Inc, Teleflex Medical, TransEnterix, Vascular Designs, WuXi AppTec, Wound Management Technologies, & Zenalux Biomedical.

Tags for this Online Resume: Project Management, Research , Medical Devices, In-vitro Diagnostics, Design Controls (DHF), Cross functional leadership, MS Project, Illinois

Mechanical Engineer - 16 Years of Experience - Near 15220

Engineering & Architecture Resumes - Mechanical Engineer Resumes - Pittsburgh, PA

Professional Summary An Engineering and Management Professional with extensive experience in Product Development and Engineering Consulting. Managerial Competencies * Service Delivery * Project management * Customer management * Onboarding new team * Performance management Technical Competencies Medical Devices/Life Sciences * Design remediation of medical devices * Remediation of Knee implant parts * Reverse engineering * ...

Tags for this Online Resume: Consulting, Medical Devices, Engineering Design, Engineering, Product Development, Documentation, Ansi (Am Natl Stds Inst), FDA

Microbiologist - 20 Years of Experience - Near 80503

Science & Biotech Resumes - Biological Technician Resumes - Longmont, CO

Summary Experienced, Self-motivated and Results-Oriented Quality professional with >25 years in the biotech/pharma and medical device industries. Experience hosting FDA and international regulatory agencies. In depth knowledge of compliance to 21 CFR parts 210 and 211, 21 CFR Part 11, 21 CFR part 820, ISO 13485, ICH Q1A-F, Q7, Q8, Q9, Q10, USP, EP, JP Testing. Knowledge and experience with GxP auditing. Chemical and Microbi...

Tags for this Online Resume: Validation, Lab Management, QMS, Compliance, Pharmaceutical, DS, DP, Research and Development, Microbiology, Manufacturing

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Director of Quality & Regulatory- 22 Years of Experience - Near 45142

Manufacturing & Production Resumes - Director of Quality Resumes - Lynchburg, OH

Summary Twenty-two years in the Medical Device Manufacturing Field, including 16 years of Director level experience in Quality Managements Systems, Regulatory Affairs and Quality Assurance/Quality Control Activities. Knowledge and professional experience in the following areas: Quality, Engineering and Manufacturing Implemented practical oversight of the following: * ISO13485 * ISO9001 * 21CFR820 (FDA) * ISO14971 Risk Manag...

Ideal Companies: A company with suability, growth and development of their employees.

Tags for this Online Resume: Audit, Engineering, Management, Management Review, Manufacturing, Medical, Quality, Quality Assurance, Quality Control, Regulatory Affairs, steel, medical device, medical devices, Quality Director, Director of Quality & Regulatory

Biochemist - 4 Years of Experience

Science & Biotech Resumes - Biochemist Resumes - Gaithersburg, MD

Tags for this Online Resume: pharmaceutical, sas, endotoxin, assay, product development, gmp, glp, dhf, sop, Research

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Senior Software Quality Engineer -- Software Quality Assurance – IT & Quality Audit - Project Management (PMP)

Healthcare & Medical Resumes - Quality Assurance Director Resumes - La Mesa, CA

Accomplished technology professional with extensive experience leading Software Quality Assurance, Quality Audit and compliance, IT Audit, Project Management, and providing technical trainings across various large-scale medical industries.

Ideal Companies: Medical Device, Medical