Quality Engineer

Elevation Recruitment Group are seeking a highly skilled and motivated Quality Engineer for a growing medical devices business in Bradford. Reporting into the Engineering Manager, the role will be to lead and support the quality function, overseeing the maintenance and continuous improvement of the Quality Management System (QMS), fostering a culture of quality across all departments.

The successful candidate will ensure regulatory compliance, drive supplier quality performance, and support technical teams with problem-solving and process improvement initiatives.

• Lead day-to-day support and maintenance of the QMS to ensure its continued effectiveness.
• Serve as the primary contact for customer complaints, external audits, and quality issues, guiding teams in investigations and resolution.
• Champion a culture of quality throughout the organization and encourage continuous improvement initiatives.
• Collaborate with suppliers to resolve quality issues and ensure consistent performance.
• Prepare and present detailed quality and environmental performance reports for senior management and the board.
• Lead teams in the development and execution of FMEAs, risk management plans, and risk management reports.
• Play an active role in the internal auditing team, ensuring compliance with audit schedules for all manufacturing sites.
• Work closely with suppliers to investigate root causes of quality issues and drive corrective actions.
• Support purchasing and materials teams in the creation of supplier performance reporting.
• Assist in the management of PPAP requirements and new product introductions.
• Conduct environmental audits and support related reporting activities.
• Support manufacturing teams with the creation of Standard Operating Procedures (SOPs).
• Collaborate with R&D in testing and introducing new products.
• Contribute to external QMS audits and support the development of company literature, including instructions for use.

• Extensive experience in plant-based manufacturing
• Experience working with ISO 9001, ISO 14001, and ISO 13485 quality management standards.
• In-depth knowledge of Medical Device Regulations (MDR) for Class I and IIa products.
• Strong understanding of FMEAs, risk management processes, and quality systems.
• Internal auditing qualification (ISO 9001 minimum).
• Proficiency in problem-solving techniques, including 8D, 5 Whys, and Ishikawa diagrams.
• Experience in liaising with suppliers on complaints, corrective actions, and PPAP submissions.