Tucker Parker Smith Group (TPS Group)

Quality Assurance Analyst

Hercules, CA, US

$45/hour
8 days ago
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Summary

Post Market Performance Follow (PMPF) Analyst (Medical Device)

Location: Hercules, CA. ONSITE M-F start (7-9 flex and end 4-6)

1 Year Assignment (Great potential to extend or convert)

Pay Rate: $45/hr.



On behalf of our client a medical device company. We are seeking for a Post Market Analyst. As a PMPF Analyst your activities involve managing and executing post-market follow-up processes. This includes reviewing scientific literature and coordinating with teams such as R&D, Clinical Affairs, Marketing, and RA/QA to collect inputs for Post Market Performance Follow-Up reports. You will participate in new product development and sustaining projects, executing studies in the laboratory as required.



Responsibilities:

  • Execute PMPF process and assures tasks are carried out by overseeing the generation and scheduling of Post Market Performance Follow up reports.
  • Coordinates PMPFR inputs among cross-functional teams (R&D, Clinical Affairs, Marketing, RA/QA) to obtain deliverables responsible for revision of PMPF Plans and PER, as needed.
  • Review and analyze scientific literature and summarize findings in applicable protocol reports.
  • Guarantee all PMPF deliverables are prioritized, executed and aligned according to the Periodic Safety Update Report Publication timeline.
  • Participate in new product development and sustaining projects as required, ensuring all tasks are completed accurately and on schedule.


Qualifications and Education:

  • BS in science related field (Biochemistry, Biotechnology, Chemistry or related field) and 1+ year 2+ years of hands-on experience.
  • Knowledge of immunoassays, infectious diseases, bacteriology and related diagnostic techniques/instruments with lab experience.
  • Experience in the in-vitro diagnostics industry preferred with familiarity IVDR regulation 2017/746.
  • Proficient use of applications: Word, Excel, Power Point, OneDrive, SharePoint, Teams

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