Lead Quality Engineer - Compliance and PMS
This role is a full-time, permanent position working 37.5 hours per week. Monday-Friday.
* To ensure compliance with all relevant regulations, the successful candidate will be responsible for creating and/or updating Product Risk and Post Market Surveillance (PMS) activities.
* The post holder will implement and maintain PMS processes and create new and updated existing Product Risk Management Documentation to ensure compliance with current procedures.
Responsibilities:
* Create and/or update PMS documentation 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.
* 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.
Required Skills and Qualifications:
* 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).
Benefits: This role offers a competitive salary and benefits package.
Others: The successful candidate must hold the full right to work in the UK.