Elevation Recruitment Group are currently recruiting a Quality Manager for a medical devices manufacturer in Leeds to lead on the quality function, ensuring excellence across product inspection, validation, compliance, and continuous improvement activities.
Key Duties & Responsibilities:
* Lead, coach, and develop the Quality Engineering and Quality Control teams to deliver exceptional quality performance and timely product release.
* Manage day-to-day quality operations, including nonconformance investigations, CAPA, SCARs, and change control.
* Support internal and external audits and technical submission reviews in accordance with ISO 13485, MDR 2017/745, and 21 CFR 820.
* Provide technical input for process validation (IQ, OQ, PQ) and risk management activities (PFMEA, DFMEA) per ISO 14971:2019.
* Oversee calibration, preventive maintenance, and labelling processes to meet regulatory standards.
* Lead root cause analysis and quality improvement projects using Six Sigma and Lean methodologies.
I'm keen to speak to experienced Quality Manager's with the following skillset:
* Bachelor’s degree (or equivalent) in Engineering, Science, or a related technical field.
* Extensive experience in a management role within a Class III medical device organisation.
* Strong working knowledge of ISO 13485, MDR 2017/745, and 21 CFR 820.
* Skilled in CAPA, validation, risk management (ISO 14971), and root cause analysis.
* Experienced in Lean and Six Sigma tools.