Quality Engineer - Process (Secondment Opportunity)
UK Visa Sponsorship Analytics
Analytics are greyed out due to low classification confidence (42.0%).
Occupation Type
Production and process engineers
Occupation Code Skill LevelHigher Skilled
Sponsorship Salary Threshold
£45,000
(£23.08 per hour)
Occupation rate applies
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Description
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
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.
- 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.
- 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.
- 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.
- A relevant science or engineering degree.
- Six Sigma Green Belt (minimum).
- Proven experience in Quality Engineering within a medical device or regulated manufacturing environment.