Lead Quality Engineer – Compliance and PMS

Job title: Lead Quality Engineer – Compliance and PMS

Job Type: Permanent, full-time position

Location: Midlothian, Scotland (Hybrid - 3 days per week on site)

Remuneration: Up to £40,000 + benefits

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 37.5 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 products are maintained in compliance with all relevant Regulations.

Responsibilities will include:

·      Create and/or update PMS documentation (i.e. PMS Plan/Report, PMPF Plan / Report, PSUR) for the 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.

Experience 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).

For more experience, please reach out to me at [email protected]

This role does not offer sponsorship, so you must hold the full right to work in the UK.