Lead Quality Engineer – Compliance and PMS Job Type: Permanent, full-time position
Midlothian, Scotland (Hybrid - 3 days per week on site)
Cpl is partnering with a leading diagnostic business that are recruiting for a Lead Quality Engineer to join our Quality Team. This role is a full-time, permanent position working 37.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 products are maintained in compliance with all relevant Regulations.
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.
Experience working in a medical device/IVD/Biotech industry.
Experience in risk management.
Exposure of participating in regulatory audits and interaction with inspectors/auditors.
Experience creating / reviewing risk management file documents (e.g.