SRG are working with a global biotechnology and healthcare organisation to help them find a Quality Engineer with expertise in Risk Management and Post Market Surveillance specialist to join the team.
The company offer a comprehensive benefits package along with opportunity for development.
The Role:
1. Create and/or update PMS documentation (i.e. PMS Plan/Report, PMPF Plan / Report, PSUR) in line with IVDR requirements and in accordance with the agreed PMS schedule.
2. Implement and maintain the PMS processes
3. Responsible for creation and maintenance of product Risk Management Files, including RMP, FMEA, BRA, RMR, in line with required standards.
4. Lead and/or support Product Risk Management activities according to current procedures for existing products and new product development projects.
5. Ensure RMF is consistent with product labelling and clinical risks
6. Create new and update existing Product Risk Management Documentation to ensure compliance with current procedures
7. Promote risk culture across the site including Risk Based Approach and Continuous Improvement
8. Participate in audits (regulatory inspections, certification or third party) as PMS / Risk SME.
9. Provides support, and training as needed to fellow team members in the areas of Risk Management and PMS
10. Ensure Post Market Surveillance and Product Risk Management Process efficiency according relevant KPIs.
Requirements:
11. Degree in relevant scientific discipline
12. Experience in medical device/IVD/Biotech industry is preferred
13. Experience in risk management
14. Experience carrying out Post Market Surveillance activities (PMS)
15. Experience creating / reviewing risk management file documents
16. Experience creating / reviewing PMS documentation
17. Ability to analyse data and author reports