Quality Engineer
Job Title: Quality Engineer II (Complaints)
Reports to: Senior Quality Engineer – Complaints
Contract: 12-month contract (hybrid)
Overview
An opportunity is available for a Quality Engineer to join a complaints investigation team within a cardiovascular medical device function. The role focuses on supporting investigations, ensuring high-quality complaint handling, and contributing to continuous improvement initiatives within a growing business area.
Purpose of the Role
Provide Quality Engineering support to the complaint investigation process, ensuring high standards in investigation quality, regulatory compliance, and adherence to quality systems, with a strong focus on patient safety and product quality.
Key Responsibilities
- Review and approve complaint investigations within a global complaints management system
- Conduct complaint investigations, including lab testing of returned devices where required
- Perform root cause analysis and define appropriate investigation pathways
- Analyse product and process performance using data analytics tools
- Prepare and present complaint trend data to relevant review forums
- Drive continuous improvement in investigation methods and processes
- Make decisions on escalation pathways and work independently when required
- Ensure compliance with all applicable quality system regulations
- Collaborate with cross-functional teams including Quality, R&D, Operations, and Field Support
Requirements
- Level 8 qualification in a STEM discipline with 2–3 years’ relevant experience
- Strong problem-solving, process improvement, or project management skills
- Ability to take initiative and drive improvements
- Knowledge of product design, manufacturing, or clinical use (advantageous)
- Strong analytical, communication, and organisational skills
- Ability to work both independently and within a team
- Experience with imaging review (advantageous)
- Willingness to complete required health and safety training for handling returned products
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