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Online Resumes with "fda "



QA Manager, document Control

I have over 30 years of experience in the medical device, pharmaceutical, and biologics experience with a strong background in Class III Medical Device Safety and pharmaceutical quality and compliance. My management background included coordinating inspection assignments, managing investigation activities and assigning investigation tasks to all involved departments, preparing summary reports, reporting metrics for complain...

Highly skilled leader with a vast technical background

I have been a leader in the IT field by introducing innovative ideas and fostering a strong work environment throughout my career as both a technical engineer and a manager. Through continuous quality improvement and enhancing customer experience, I have influenced revenue growth.

Ideal Companies: Vanguard, Comcast, Google, Cisco

Tags for this Online Resume: Manager, Director, Technology, Cisco

Quality Assurance Professional, Tampa

Motivated, personable business professional with 10 years of experience in Quality within the medical device industry. Accustomed to handling compliance and quality support for FDA, ISO13485, MDD, CMDR and JPAL products. Accomplished in Quality System Regulation implementation and improvement activities, auditing, CAPA investigations, root cause analysis, customer complaints, validations and process improvements. Demonstrat...

Tags for this Online Resume: quality, engineer, quality assurance, biology

Featured Profile

Technical Writer - 20 Years of Experience - Near 02180

An Engineer for ten years writes for Engineers and other disciplines for 17 years. Specializing in technical documentation for military and commercial customers, as well as quality and regulatory documentation for the medical device industry, a seasoned Technical Writer providing engineering and writing solutions to New England’s high tech arena since 1985, is now ready to put that experience to work in an ambitious writ...

Tags for this Online Resume: Technical Writer, Policy Writer, Quality Specialist, Regulatory FDA IEC ISO, military standards: MIL-STD-40051-2A, MIL-HDBK-1222D, MIL-STD-38784, U.S. Government Printing Office Style Manual, Management, Microsoft, Microsoft Word, Troubleshooting, Instrumentation, Microsoft Excel, Technical Writing, Manufacturing

Sr Mechanical Designer CAD ProE

I am a Mechanical Designer/CAD with extensive experience in ProEngineer. I have extensive multi-year experience working in a variety of industries including Aerospace, Medical and Automotive. I have worked with governing agencies such as FDA, ISO, MIL.

Tags for this Online Resume: CAD, ProE, Designer, Drafter, Mechanical

Sr. Analytical Research Scientist

To seek a position in the R&D laboratory or analytical operations of a pharmaceutical or chemical or food company where I can utilize my knowledge and expertise in analytical method development and validation, technical support for formulation development and trouble shooting, FDA deficiency response, and internal and external project management.

Tags for this Online Resume: HPLC, GC, DISSOLUTION, Analytical Development, Pharmaceutical R&D, Analytical Scientist

Medical Device Engineer

I am interested in and trained to work for medical device companies. I have excellent experiences investigating medical devices by using finite element analysis. From original drawing of the device, simulations will be carried out to propose possible modifications to optimize the design.

Tags for this Online Resume: Biomedical Engineer, Finite Element Analysis, Cardiovascular Disease, Medical Device, Mechanical Engineering , AutoCAD, ISO 13485, FDA 510K, Product Development

Quality Assurance Manager, Auditor

Professional Scientist with extensive experience in quality control, quality assurance, auditing and regulatory compliance. Expertise in deviation, investigation, CAPA and method/specification development. In-depth knowledge of FDA and ICH regulations. Proven track record of hiring, coaching, motivating, empowering and managing people. An excellent communication, leadership and conflict management skills with ability to org...

Tags for this Online Resume: quality assurance, deviation, investigation, CAPA, LIMS, cGMP

Senior Quality Assurance Auditor, Sterile and Non-sterile clinical manufacturing

Tags for this Online Resume: GMP, CAPA, FDA, Clinical , Sterile Manufacturing, MDI/DPI Manufacturing

OPERATIONS MANAGER

Operations of distribution and or retail business company that values performance and employee dedications.

Ideal Companies: Sysco, Mohawk Flooring, Armstrong.

Tags for this Online Resume: Operations Manager, Distribution Manager, Warehouse Manager

FDA Legal Advisor

With 30 years of experience in FDA legislative, regulatory, and legal matters, I would like to work for a law firm or organization providing legal, legislative, and regulatory advice to the food, drug, and/or medical device industry.

Tags for this Online Resume: FDA, Medical Device, Biotech , Drug Regulation, Biologicals