Quality Assurance Analyst

Tucker Parker Smith Group (TPS Group); Hercules (CA); On-site; Full time

Job summary

A leading medical device company is seeking a Post Market Performance Follow (PMPF) Analyst to manage post-market follow-up processes. This role involves coordinating with cross-functional teams, reviewing scientific literature, and participating in product development. Ideal candidates will have a BS in a science-related field and relevant experience in the diagnostics industry. This is a contract position with potential for extension.

Qualifications

• 1-2 years of hands-on experience in a science-related field.
• Familiarity with IVDR regulation 2017/746 preferred.

Responsibilities

• Manage and execute post-market follow-up processes.
• Coordinate inputs among cross-functional teams.
• Review and analyze scientific literature.

Skills

Knowledge of immunoassays

Knowledge of infectious diseases

Knowledge of bacteriology

Education

BS in a science-related field

Tools

Word

Excel

PowerPoint

OneDrive

SharePoint

Teams

Job description

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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 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 ensure tasks are carried out by overseeing the generation and scheduling of Post Market Performance Follow-up reports.
• Coordinate PMPFR inputs among cross-functional teams (R&D, Clinical Affairs, Marketing, RA/QA) to obtain deliverables and revise 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 a science-related field (Biochemistry, Biotechnology, Chemistry, or related field) with 1+ to 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 is preferred, with familiarity with IVDR regulation 2017/746.
• Proficient in applications: Word, Excel, PowerPoint, OneDrive, SharePoint, Teams.

Seniority level

• Mid-Senior level

Employment type

• Contract

Job function

• Analyst, Research, and Science

Industries

• Medical Equipment Manufacturing

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