Lead Quality Engineer

AliveDx is a global leader in transfusion diagnostics, with over 30 years of experience supporting laboratories through a portfolio of high-quality serological reagent solutions. The Alba product range is trusted by hospitals, blood services, and laboratories to ensure the safety and efficiency of transfusion testing. AliveDx operates across sites in Eysins (Switzerland) and Edinburgh (Scotland).

LEAD QUALITY ENGINEER

We are recruiting for a Lead Quality Engineer to join our Quality Team based at our ARC site near Penicuik, EH26 0BF. This role is a full-time, permanent position working 37.5 hours per week. Monday-Friday.

The focus of this position is to ensure, through completion of the relevant Product Risk and Product Post Market Surveillance (PMS) activities, that Alba Bioscience products are maintained in compliance with all relevant Regulations.

JOB DESCRIPTION
The main responsibilities will include:

• Create and/or update PMS documentation (i.e. PMS Plan/Report, PMPF Plan / Report, PSUR) for the Alba Bioscience products 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 updated existing Product Risk Management Documentation to ensure compliance with current procedures

• Promoting 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.

QUALIFICATIONS, EXPERIENCE & BEHAVIOURS REQUIRED

• A relevant degree or equivalent qualification
• Experience working in a medical device/IVD/Biotech industry
• Experience in risk management
• Experience carrying out Post Market Surveillance activities (PMS)
• Exposure of participating in regulatory audits and interaction with inspectors/auditors.
• Experience creating / reviewing PMS documentation (e.g. PMS Plan, SSP, PMS Report, PMPF Plan / Report, PSUR)
• Experience creating / reviewing risk management file documents (e.g. RMP, RMR, FMEA, BRA)

• ADDITIONAL INFORMATION
• Competitive salary on offer.
• AliveDx offer a range of core and flexible benefits ranging from private medical cover, life assurance, cycle to work, technology, and restaurant discounts.