Quality Engineer – Medical Devices

About the role

The Quality Engineer is responsible for upholding the Quality Policy, ensuring patient safety and product quality through daily execution of robust quality practices. You will work within a highly regulated medical device environment, collaborating with cross‑functional teams to maintain an effective quality system.

Key responsibilities

• Identify and resolve complex exceptions to work assignments.
• Analyze test results and process data to draw conclusions and make quality decisions.
• Make independent decisions on product quality, including disposition of non‑conforming items.
• Participate in customer complaint investigations for assigned areas.
• Drive continuous improvements in product and process quality.
• Apply QSR, ISO/MDD, and BS EN 14971 standards to daily activities.
• Conduct validation activities and ensure compliance with regulatory requirements.
• Evaluate new equipment, processes, and chemicals for environmental impact in collaboration with EHS.
• Compile and analyse operational, test, and validation data to define specifications.
• Support new product or technology transfers to meet internal and regulatory standards.
• Provide technical guidance to associate engineers, technicians, and inspection staff.

Required profile

• Level 8 degree (240 credits) or equivalent in Engineering or a Science discipline.
• 3–5 years of engineering experience, preferably in the medical device industry or another highly regulated sector.
• Familiarity with internal audit processes.
• Strong commitment to teamwork and best‑practice implementation.

Required skills

• Six Sigma methodology
• Statistical analysis
• Lean principles
• Risk management (BS EN 14971)
• Quality System Regulations (QSR)
• ISO/MDD standards
• Validation techniques and regulatory compliance
• Internal audit processes