Job Description
Quality Engineer - Medical DevicesLocation: Southminster, EssexSalary: £40,000Job 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
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