Quality Engineer - Medical Devices Location: Southminster, Essex Salary: £40,000 Job Type: Full-Time, On-Site Are you passionate about quality and ready to take your next step in the medical device industry? A leading manufacturer is seeking a Quality Engineer to support the development and delivery of high-quality products across the full product lifecycle. This is a hands-on, full-time position based on-site at a modern facility in Essex - just a 2 minute walk from Southminster train station. About the Role Reporting to the Quality Manager, you'll work closely with cross-functional teams to ensure quality is embedded at every stage of the process - from concept to production. You'll also act as a key point of contact for both internal teams and customers regarding quality assurance for a specific portfolio of products. Key Responsibilities Act as the Quality Assurance liaison for internal teams and customers Support validation and verification activities, both internal and customer-led Define in-process inspection criteria using process outputs Assist with the creation and maintenance of product Technical Files (CE/UKCA) Contribute to the improvement of internal processes and the Quality Management System Lead problem-solving activities (e.g. RCA, CAPA, 8D) Manage change control processes in line with quality requirements Support internal and supplier audits, ensuring corrective actions are implemented Promote quality awareness across the business and assist with training activities What We're Looking For Experience working within a regulated industry (medical device, pharmaceutical, or similar) Qualification in an engineering or technical discipline Knowledge of standards such as ISO 9001, ISO 13485, MDD/MDR, CFR Part 820, ISO 14971 Hands-on experience with quality tools and techniques (FMEA, RCA, CAPA, 5 Whys, APQP, etc.) Familiarity with Technical File and maintenance for CE/UKCA marking Excellent communication, time management, and organisational skills Proficiency in statistical analysis tools (e.g. Minitab) Lean Six Sigma experience is desirable Working Conditions Occasional work in a cleanroom environment with full PPE required On-site role only - this position is not suitable for remote or hybrid working SER-IN