We’re looking for a driven and detail‑oriented Quality Engineer – Process Quality to join our high‑performing Quality Assurance team on a fixed term contract for 12 months. In this role, you’ll support R&D, Manufacturing, and Quality functions across a wide range of projects, ensuring our products and processes meet the highest global regulatory standards. You’ll play a key part in fostering a culture of continuous improvement, operational excellence, and regulatory compliance.
What You’ll Do
Quality Engineering & Compliance
* Support design and manufacturing‑led projects with expert Quality Engineering input.
* Lead and contribute to CAPA and complaint investigations, including root cause analysis.
* Ensure compliance with global regulatory standards (EU MDR, ISO 13485, FDA 21 CFR 820, MHLW Ordinance 169, and others).
* Maintain audit readiness across processes, documentation, and facilities.
Cross‑Functional Collaboration
* Represent Quality on design teams and process improvement initiatives.
* Work closely with R&D and Manufacturing to develop test protocols, validation plans, and IQ/OQ/PQ documentation.
* Support execution and oversight of validation activities.
* Partner with teams to resolve product and process quality issues using structured problem‑solving tools.
Data, Documentation & Systems
* Provide trending data and reports to senior management, regulators, and customers.
* Support validated test method development and contribute to dFMEA and pFMEA improvements.
* Champion the use of MasterControl for managing protocols, reports, validation data, and engineering change records.
* Maintain the Computer System Validation inventory list.
Training & Continuous Improvement
* Develop training materials for design and manufacturing teams on validation requirements.
* Contribute to process‑based procedures for design control, V&V, and IQ/OQ/PQ.
* Assist with validation of new tools, equipment, and processes.
* Build strong internal and external relationships to support quality and regulatory compliance.
What You’ll Bring
* A relevant science or engineering degree.
* Six Sigma Green Belt (minimum).
* Proven experience in Quality Engineering within a medical device or regulated manufacturing environment.
* Strong understanding of global medical device regulations and Quality Management Systems.
* Experience supporting design and validation teams in a global organisation.
* Working knowledge of Minitab or similar statistical tools.
* Excellent analytical, problem‑solving, and communication skills.
* Ability to manage multiple priorities in a fast‑paced environment.
* Strong IT skills, including Microsoft Office and willingness to learn QA systems.
* Ability to influence change through clear, structured communication.
* A collaborative mindset and the ability to build effective cross‑functional relationships.
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