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Georgetown, SC

Georgetown, SC

Georgetown, SC

Georgetown, SC

Georgetown, SC

Medical Director
Eagan, MN

Director Regulatory Affairs
Eagan, MN

Miami, FL

Our Clients
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 File No.  EFB2E3
 Location  New Cumberland
 Designation/Title  Quality Manager
  • Effectively manage processes and personnel to ensure the quality of incoming, in-process, and finished medical devices. Work is performed in keeping with production deadlines and customer needs.
  • Review product specifications and quality requirements for regulatory compliance and determine necessary product requirements not specified by the customer. Requirements developed include dimensional tolerances, functional performance, packaging, and labeling.
  • Responsible for the development, maintenance, and audit of the requirements, methods, and procedures of an effective Quality Management System in compliance with ISO 9001, ISO 13485, and 21CFR standards for medical device design, development, manufacturing, labeling, and distribution. Responsible for developing and implementing a Quality Management System that received accredited certification for compliance with requirements of both ISO 9001:2000 and ISO 13485:2003. Consistently received a Quality rating of 90 or greater from major customer BBraun Medical, Inc. 
  • Maintain both electronic and hard files for document control. Electronic files maintained in MS Excel, MS Word, Access, and Acrobat software.
  • Develop and implement process validation protocols and analyses of validation results to ensure that production processes and equipment are controlled and are capable of consistently producing product that meets established specifications and quality requirements. Processes validated include vision inspection systems, injection and compression mold processes, and Controlled Environment cleaning.
  • Obtain and review qualifications of potential suppliers to ensure that the product or services provided meet established requirements. Also perform periodic audits of current suppliers to ensure continued compliance with regulatory standards and identify opportunities for improvement.

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