Quality Operations Manager

X4 Life Sciences are partnered with a well‑established medical device organisation in an exciting growth phase. They are looking to hire hands‑on Operations Quality Manager who will take ownership of all manufacturing‑related quality activities.

This role is centred on overseeing day‑to‑day quality performance on the production floor and ensuring products are built safely, consistently, and in compliance with internal standards and regulatory expectations. The ideal candidate will be confident making independent quality decisions, experienced working across Manufacturing, Engineering, Supply Chain, and Operations, and capable of leading a small quality team.

• Oversee all Quality Control activities, including inspection planning, sampling, and disposition.
• Lead improvements that enhance product quality, operational efficiency, and overall yield while reducing risk.
• Manage and develop the QC Supervisor, Quality Engineers, and inspection team.
• Act as the key decision‑maker for deviations, product acceptance, and quality‑related risks.
• Own the nonconformance process and ensure timely investigations and closures.
• Analyse NCR/MRB trends and feed insights into CAPA and continuous improvement.
• Ensure consistent quality practices across in‑process checks, final inspections, and product release.
• Apply Lean/Six Sigma methods to strengthen processes and product quality.
• Support new equipment, processes, and product introductions with proper quality and risk planning.
• Maintain compliance with ISO 13485, FDA requirements, and other relevant regulations.
• Support audits and inspections alongside QA/RA leadership.
• Drive CAPA, change control, and risk management within manufacturing.
• Collaborate closely with Operations, Engineering, Supply Chain, and Manufacturing to embed quality throughout production.
• Support supplier‑related quality needs affecting manufacturing performance.
• Provide clear, data‑driven reporting on quality performance and risks.

• 6+ years of quality experience within medical device manufacturing.
• At least 3 years leading Quality Engineering and/or QC teams.
• Hands‑on experience with manufacturing quality systems, NCR/MRB processes, and shop‑floor quality execution.
• Strong understanding of ISO 13485 and risk‑based quality approaches.
• Demonstrated ability to make sound, independent decisions in fast‑moving manufacturing environments.
• Bachelor’s in Mechanical, Electrical, or related engineering discipline
• Background working with complex, low‑volume medical technologies, e.g. radiation systems, imaging devices (preffered).