Senior Quality Assurance and Regulatory Affairs Engineer in Swindon

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 ...