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Post Market Surveillance QA Associate

Company: The Mice Groups, Inc.
Location: Mountain View
Posted on: June 22, 2022

Job Description:

Our Client is seeking a Post Market Surveillance QA Associate for a Direct Hire/FTE position in Mountain View, CA.Summary:This position will be responsible for all aspects of the Client's Post Market Surveillance program including but not limited to maintaining and implementing processes for complaint handling, serious adverse event/vigilance reporting, data analysis, trending and review of risk documentation. It will work cross functionally with Sales, Marketing, Technical Service, Customer Service, Operations and Regulatory teams to assure all procedures and processes supporting post market surveillance and complaint handling activities are sustained in compliance with all applicable regulatory and procedural requirements.Responsibilities:

  • Oversee and maintain the complaint handling process supporting both Headquarters and Pascal divisions.
  • Review incoming complaints, conduct investigations, follow up with customers, document relevant data, evaluate and close complaint records.
  • Review, document and evaluate post market feedback; escalate feedback to Engineering and Management as appropriate.
  • Work collaboratively with the QE and QA Manager to generate timely trend analysis and reporting.
  • Host and lead monthly cross functional review of adverse events.
  • Work with Clinical Affairs to review and document serious adverse events identified from literature review.
  • Work with Marketing and Regulatory Affairs to prepare and issue customer surveys and document results.
  • Participate in compilation, revision and review of Clinical Evaluation Reports (CERs).
  • Continually evaluate post market surveillance procedures and processes.Required Skills:
    • Minimum 5 years' experience performing post market surveillance activities including complaint handling, serious adverse event and vigilance reporting.
    • Knowledge of applicable serious adverse event reporting requirements in MDSAP participating countries (e.g. USA, Canada, Brazil, Japan and Australia).
    • Excellent written and spoken English skills; additional languages a plus.
    • Computer literacy is required; proficiency in MS Office Suite and ability to learn ERP and PLM processes and other systems as needed to perform the duties of the position.
    • BS or BA degree in science or engineering related field preferred.

Keywords: The Mice Groups, Inc., Mountain View , Post Market Surveillance QA Associate, Other , Mountain View, California

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