Quality Manager – ISO13485 in Sterile Services

About the role

The Quality Manager will lead the implementation and maintenance of the ISO 13485 quality management system for the Sterile Services Department at Broadgreen Hospital. Reporting to the Sterile Services Manager, you will ensure compliance across decontamination, re‑processing and distribution of surgical instruments for multiple hospital sites.

Key responsibilities

• Develop, implement and monitor ISO 13485 procedures covering receipt, sorting, decontamination, packaging, sterilisation, storage and dispatch of surgical instruments.
• Conduct internal quality audits and support external notified‑body inspections, providing required documentation and validation reports.
• Maintain the department’s accreditation by updating work instructions and ensuring staff adherence to the QMS.
• Communicate procedural changes to SSD staff and track performance against QMS requirements.
• Attend unannounced notified‑body visits and coordinate corrective actions.

Required profile

• Significant experience in surgical instrument re‑processing or a similar medical‑device environment, preferably at a supervisory level.
• Demonstrated knowledge of ISO 13485 and the Medical Devices Regulations (MDR) 2017‑745.
• Proven ability to lead internal audits and manage external audit interactions.
• Strong attention to detail and commitment to maintaining rigorous quality standards.

Required skills

• ISO 13485 quality management system
• Medical Devices Regulations (MDR) 2017‑745
• Internal quality auditing
• External notified‑body audit coordination
• QMS documentation and validation reporting