Senior Quality Assurance and Regulatory Affairs Engineer
Your new company You will be joining a growing UK medical device manufacturer based in the Swindon area. The organisation develops and supplies products that improve the everyday lives of patients undergoing chronic and complex medical treatment. Operating within a highly regulated environment, the business is continuing to invest in its manufacturing capabilities, product portfolio and international growth.
Your new role As Senior Quality Assurance and Regulatory Affairs Engineer, you will strengthen the company's Quality and Regulatory function while working closely with Manufacturing, Operations, R&D, Product and Marketing teams. This is a broad, hands-on position where you will take ownership of quality improvement activities, non-conformances, CAPA, root-cause investigations, risk management, complaint handling and process improvement. You will also support design controls, new product introduction, supplier quality, change control and the maintenance and remediation of Technical Files and Design History Files. You will be regularly present within the manufacturing environment, investigating issues at source and ensuring the Quality Management System supports safe, compliant and effective operations.
What you'll need to succeed You will have: Previous Quality Engineering experience within medical devices or another highly regulated manufacturing environment Strong knowledge of ISO 13485 and medical device quality systems Experience managing non-conformances, CAPA and root-cause investigations Knowledge of quality tools such as 8D, 5 Why, Fishbone, FMEA and structured problem-solving Experience supporting manufacturing process controls, change control and continuous improvement Strong technical documentation skills, including SOPs, work instructions and process-flow documentation Good knowledge of UK MDR and EU MDR, particularly Technical File generation, maintenance or remediation A relevant engineering, scientific or technical qualification Experience with ISO 14971, design controls, process validation, complaint handling, supplier quality or internal auditing would be advantageous.
What you'll get in return You will receive a competitive salary or contract rate, dependent on your experience, alongside the opportunity to join a growing medical device business at an important stage of its development. This is an excellent opportunity to take on a varied and influential position that combines Quality Engineering, Regulatory Affairs and manufacturing improvement. You will have the opportunity to work across the full product lifecycle, improve established processes and make a visible contribution to quality performance and regulatory compliance. This is a full-time role requiring regular on-site presence in the Swindon area due to its close involvement with manufacturing operations.
What you need to do now If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.