Quality Engineer

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