Quality Lead- PMS and Risk Management

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.