JVT Advisors

Quality Manager

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Location: Sunnyvale, California 94089
Employment Type: Contract

Job Description

Contract length: 12 Months

Job Summary: Responsible for ensuring Quality Management System (QMS) is compliant with required regulations and applicable standards. Drives activities to maintain compliance and meet new regulatory requirement.

Responsibilities:

  • Champion and advocate for Quality Management System (QMS)
  • Manages and maintains the following functions/processes within the QMS: Management Review, Corrective & Preventative Action, Internal Audits, Document Control & Employee Training
  • Participates in local Management Quality Review Meetings. Prepares and presents reports assessing the suitability and effectiveness of assigned areas of the quality system
  • Provides appropriate training on quality system procedures as required and complies with all quality system procedures

Requirements:

  • Bachelor’s degree (BA or BS) in a technical discipline preferred
  • 4-6 years related experience in a medical device or pharmaceutical company or equivalent combination of education and experience required
  • Excellent working knowledge of medical device Quality System Regulations (21CFR820), ISO 13485, MDD, CMDR, MHLW Ministerial Ordinances and Brazilian requirements
  • Knowledge in device regulatory affairs desired. Computer literate: able to use word processing, spreadsheet programs, databases
  • Strong knowledge of corrective action, problem solving and root cause analysis processes and tools.

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