QA - Risk and Post Market Surveillance

Thermo Fisher Scientific Dartford, England

About the Job

Reporting to the Risk and PMS Manager the successful applicant will join the IVDR Project working closely with QA teams at multiple sites to support collation of the risk management and Post Market Surveillance (PMS) files for the extensive product portfolio.

This position is a fixed term contract with an end date of May 2022.

Responsibilities:

  • Co-ordinate activities to support IVDR project on compilation of Post Market Surveillance reports, Risk management and other quality issues under the guidance of the Risk Management and PMS Manager
  • Research, collect data and respond to requests for Post Market Surveillance reports and risk management files
  • Participate in projects as a team member with specific identified deliverables.
  • Participate in programs to streamline the file collation process.
  • Collate and input data as measures and indicators to support high performance and a continuous process improvement culture.
  • Perform other work-related duties as assigned

    Minimum Requirements/Qualifications:

  • Bachelor’s degree preferred
  • Ability to effectively work with all functions to co-ordinate the generation of PMS and Risk management files
  • Must be a self-starter who can take general concepts and direction and produce desirable results
  • Ability to prioritise multiple tasks functions effectively
  • Ability to work both independently and as a team member
  • Strong quality background and problem analysis and decision-making skills
  • High attention to detail
  • Strong oral and written communication skills
  • Proficient in the use of Microsoft Office, SAP and standard computer applications

Non-Negotiable Hiring Criteria:

  • Experience working in a QA / Compliance department
  • Basic understanding of IVD, PMS and Risk Management