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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:
- 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.
- Implement and maintain the PMS processes
- Responsible for creation and maintenance of product Risk Management Files, including RMP, FMEA, BRA, RMR, in line with required standards.
- Lead and/or support Product Risk Management activities according to current procedures for existing products and new product development projects.
- Ensure RMF is consistent with product labelling and clinical risks
- Create new and update existing Product Risk Management Documentation to ensure compliance with current procedures
- Promote risk culture across the site including Risk Based Approach and Continuous Improvement
- Participate in audits (regulatory inspections, certification or third party) as PMS / Risk SME.
- Provides support, and training as needed to fellow team members in the areas of Risk Management and PMS
- Ensure Post Market Surveillance and Product Risk Management Process efficiency according relevant KPIs.
Requirements:
- Degree in relevant scientific discipline
- Experience in medical device/IVD/Biotech industry is preferred
- Experience in risk management
- Experience carrying out Post Market Surveillance activities (PMS)
- Experience creating / reviewing risk management file documents
- Experience creating / reviewing PMS documentation
- Ability to analyse data and author reports
Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.
