CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "13485"

Biomedical Engineer

SUMMARY * Extensive experience in the Pharmaceutical, Biomedical, and Semiconductor industries. * Well rounded Engineering and Business experience in Project and Operations Management, Quality Assurance, Applications, Equipment, Process, and Electronics Engineering. * Data driven, results-oriented, team-builder who strives to make significant, measurable contributions. * Thrives in complex, cross-functional, and dynamic env...

Tags for this Online Resume: Cardiopulmonary resuscitation (CPR), Diagnostic Imaging, Distribution, First Aid, Imaging, ISO, ISO 9001, Medical, NRC, Nuclear Medicine

Medical Device, Process Quality Engineer - 20 Years of Experience - Near 95376

Summary of qualifications Accomplished and experienced self-starting Quality Assurance (QA/QE/QC) professional with over 20 years' experience in class 1, class 2, and class 3 electromechanical and single use sterile medical devices. Ability to deliver and manage projects simultaneously. Extensive knowledge of QSR, and ISO13485 quality system requirements. Highly collaborative team player.

Tags for this Online Resume: Test, Quality, Documentation, Failure Analysis, Engineering, Radiation, Medical Device, ISO13485, Clean Room, Sterilization

Biomedical Engineer - 19 Years of Experience - Near 84092

Qualifications include: 19 years experience in medical device/pharma fields. 7 years experience in other industries including semiconductor mfg. and marine engineering. Team member of 3 successful medical device companies through start-up, acquisition and integration. Broad experience operating a medical device business to include: R&D, engineering, manufacturing, regulatory, QAQC, operations, finance, and sales and marketi...

Tags for this Online Resume: Medical Device, Emergency Medicine, Surgical, Engineering, Research and Development, Medical Devices, Regulatory, Qualify assurance, Manufacturing

Chemical Engineer - 14 Years of Experience - Near 77004

SUMMARY Over 7 years of diversified international experience in the Engineering sector including pharmaceuticals, oil and gas and power plants. Well-qualified to contribute in Pharmaceutical environment from Lab, Pilot Plant to FDA-compliant production. Experienced in both batch and continuous processes. Experienced in execution of validation processes, Temperature Mapping & knowledge in validation testing (IQ, OQ, PQ, RQ, ...

Tags for this Online Resume: IDS, Engineering, Evaluate, Manufacturing, Quality, sheets, Audit, Autocad, Autodesk AutoCAD, Automation

Engineer

SUMMARY: Proven engineering expert with broad global experience in medical device, drug delivery, automotive, and aerospace engineering. Served roles in R&D, Product Development, Manufacturing, Quality, Validation, & Supplier Quality Engineer. Six Sigma Greenbelt. Broad domestic and global Manufacturing & Quality Engineering experience at locations in: US: Utah, Michigan, Ohio, Indiana, Wisconsin, Minnesota, New York, & Mas...

Tags for this Online Resume: Product Development, Quality, Quality Assurance, Research and Development, Six Sigma Greenbelt, Six Sigma Quality, Aerospace, Automotive, Engineering, Global Experience, DOE, IQ/OQ/PQ, FMEA, GR&R, MSA, ISO 13485, 21 CFR 820, Process Validaiton, CNC Machining, CMM Programmer, FAI, Molding, Extrusion, CAD, Toyota Production Systems, Lean Manufacturing, Medical Device, Clean Room Validation

Operations Manager - 19 Years of Experience - Near 01886

Summary * Over 25 years of experience in high technology including electrical, electro-mechanical, optical and contract manufacturing assembly. * Have held key positions at various levels throughout my career. These included engineering management, sales and marketing, program and operations management. * Strong innovative leader with excellent planning, communication and team building skills. * Self-motivated, hands-on ind...

Tags for this Online Resume: 6S Experience, Advaced Manufacturing, Manufacturing Management, Technical background, Marketing Management, Supply Chain, Lean Manufacturing, Manufacturing Engineering, Team Building, Results oriented, Quality focused, On time delivery

Production Supervisor

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, Audit, Corrective Actions, Management, Process Improvement, Technology Transfer, Training, Change Control, Good Manufacturing Practices

Mechanical Engineer

SUMMARY Results-oriented Engineering Professional, with extensive experience designing and delivering medical, bio-medical, and scientific diagnostic instrumentation to achieve overall business objectives. A clear communicator, that is flexible and adaptable, with the ability to work effectively across organizational lines to deliver projects on schedule. A seasoned engineer and project manager, with the expertise to develo...

Tags for this Online Resume: Drafting, Engineering, Instrumentation, ISO, ISO 9000, Manufacturing, Manufacturing Engineering, Reviews, Support, Surgical

Clinical Pharmacovigilance/Drug Safety

A successful Documentation Control Management professional with over 30 years of experience in the Pharmaceutical and Medical Device industry. Excellent communication and interpersonal skills. Committed to motivating and empowering employees to consistently meet or exceed customer expectations and business needs with the following experiences: Quality Management Systems (QMS) development and implementation (QMS was based on...

Tags for this Online Resume: BPI, Documentum, Document Control, Management, Project Management, Documentation Management, Pharmaceutical, Medical Device, Biotech

Not Listed - 20 Years of Experience - Near 07936

SUMMARY I have a Quality Assurance background (various areas of QA) with experience managing and overseeing QA processes in a Pharmaceutical and Medical Device regulated environment. Produce statistical documentation and communicate with senior-level managers regarding Quality Assurance/Training issues. Provide supervision and training to QA group members. Sustain quality and compliance levels. I am skilled in the following...

Tags for this Online Resume: Manufacturing, Test, Management, Audit, Validation, Database, Documentation, Microsoft Office, Quality, Quality Assurance, Investigations, Microbiologist

Not Listed - 20 Years of Experience - Near 94704

Professional Profile Pg 3 of 3 Hanan Altschuler, Machine Builder/Technologist - Process / Mechatronics Engineer P. O. Box 265, Berkeley, CA 94701 Forensics / Productivity and Quality / Validation E-mail: hanan@lmi.net Other Specialized Experience: * Use of multi-disciplinary approach to design products incorporating optical, mechanical, electrical, chemical, biological, and other technologies in a single product with compli...

Tags for this Online Resume: ANSI, quality, Automation, Automotive, CNC, Compliance, DFS, Documentation, Engineering, Failure Analysis, R&D, industrial design

Market Research Analyst - 15 Years of Experience - Near 33408

SUMMARY High performance, proven results-driven C-level Global Marketing and Sales Manager with 15+ years leading marketing, sales forces and cross-functional new product development, new product introductions and market launch teams generating $438 Million global sales growth for leading medical device manufacturers: Baxter, Atrium Medical, Allegiance, Bayer, Cooper Vision, Pilkington Vision Care, BioElectronics and Surgif...

Tags for this Online Resume: Banking Industry, C Programming Language, Cardiovascular, Catheter, Chemistry, Citrix, Critical Care - Vascular, Customer Relationship Management, Distribution, EKG