Post Market Surveillance QA Associate
Company: The Mice Groups, Inc.
Location: Mountain View
Posted on: June 22, 2022
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
- 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
- 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
- Minimum 5 years' experience performing post market surveillance
activities including complaint handling, serious adverse event and
- 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
Keywords: The Mice Groups, Inc., Mountain View , Post Market Surveillance QA Associate, Other , Mountain View, California
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