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Quality Assurance Specialist (FDR QSR)

Location: Oakland, NJ
Gig # 11213228

Must have experience with FDA QSR Requirements

  • Responsible for analyzing and investigating of our software product complaints (related to medical device software) or reported quality issues to ensure closure in accordance with company guidelines and external regulatory requirements.​
  • Develops or updates company complaint and inspection procedures to ensure issues are captured and investigations occurs, as well as proper documentation of complaints.​
  • Maintains and analyzes problem logs to identify and report recurring issues to quality assurance management and product development.
  • Work closely with internal departments for resolution of CAPA and Supplier Corrective Action Requests.
  • May perform audits and risk assessments.
  • Assist in other Quality Assurance tasks as required.
  • Education & Experience - BS or MS in Computer Science/Computer Engineering or related fields.
  • 2-3 years experience in a quality role within a software company or direct interaction with software solution complaints
  • Familiarity with FDA QSR Requirements
  • Ability to troubleshoot, diagnose and document technical complaints
  • ServiceMax and 123Compliance experience / knowledge
  • Experience with Customer support for Software/ Hardware preferred
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