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.
As Manager, Quality Engineering & Quality Control, you will lead and develop the Quality Control and Quality Engineering teams, ensuring compliant and efficient operations aligned with ISO 13485, MDR 2017/745, and 21 CFR 820 standards.
You’ll work cross-functionally with Operations, R&D, Regulatory Affairs, and Engineering to strengthen quality performance, drive process improvements, and maintain consistency across sites.
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.
*Ensure consistent compliance and QMS alignment across global sites.
*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.
*Track key quality performance indicators, conduct trend analysis, and implement data-driven improvements.
I’m keen to speak to experienced Quality Manager’s with the following skillset: You’re an experienced quality leader with a passion for excellence, collaboration, and continuous improvement. You thrive in regulated medical device environments and bring both technical depth and people leadership capability.
Requirements:
*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.
*Proven success in leading teams and driving a culture of quality and continuous improvement.
*Skilled in CAPA, validation, risk management (ISO 14971), and root cause analysis.
*Experienced in Lean and Six Sigma tools.
*Excellent communication, analytical, and leadership skills.
*Proficient with Microsoft Office; Minitab experience preferred.