Quality Engineer - Medical Devices
Location: Southminster, Essex
Salary: £40,(Apply online only)
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 generation 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