Medical Device jobs in United States

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

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