Quality Lead- PMS and Risk Management

Job title: Quality Lead- PMS and Risk Management

Company: SRG


Job description: 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.Apply to this JobShare this JobMore InformationSubscribe to our newsletterStay up to date with SRGGet in TouchFor Job SeekersFor ContractorsInsightsAbout SRGDocumentsPart Of© SRG First Floor, Mulberry House, Parkland Square, 750 Capability Green, Luton, LU1 3LU

Expected salary:

Location: Edinburgh

Job date: Sat, 24 May 2025 22:35:09 GMT

To help us track our recruitment effort, please indicate in your email/cover letter where (jobsnear.pro) you saw this job posting.Thanks&Good Luck