About the Role
We’re looking for a dynamic Quality Engineer to join our team and play a key role in driving quality and compliance across our medical device manufacturing operations. This position is ideal for someone who thrives on solving complex problems, improving systems, and collaborating with cross-functional teams to ensure products meet the highest regulatory and performance standards.
As a Quality Engineer, you’ll help shape and sustain a robust Quality Management System (QMS), lead continuous improvement initiatives, and support validation, risk management, and audit readiness activities across the business.
Key Responsibilities
* Champion Quality: Continuously review and enhance the QMS to ensure full compliance with ISO 13485 and other applicable regulations, identifying improvements and addressing root causes effectively.
* Process Validation: Author and manage key manufacturing documentation including pFMEAs, validation protocols (IQ, OQ, PQ), and inspection plans (AQL levels).
* Cross-Functional Collaboration: Partner with Manufacturing, Quality, and R&D teams across global sites to develop and validate critical processes.
* Continuous Improvement: Use Lean, Six Sigma, and root cause analysis methodologies to optimise manufacturing processes and drive efficiency.
* Equipment Management: Oversee validation, calibration, and preventive maintenance of manufacturing and inspection equipment.
* Technical Documentation: Develop clear, compliant work instructions and training materials for production teams.
* Quality Support: Contribute to QMS documentation, design transfers, DCOs, and regulatory submissions.
* Problem Solving: Lead investigations into non-conformances, CAPAs, and audit findings, ensuring timely and effective closure.
* Audit Leadership: Take an active role in internal, external, and regulatory audits, including ISO 13485 and Notified Body inspections.
* Risk & Compliance: Support PFMEA and DFMEA activities in line with ISO 14971:2019; manage complaint handling, vigilance reporting, and regulatory notifications.
* Audit Coordination: Liaise with external auditors (e.g., BSI, MHRA) and support corrective action management.
Skills & Experience
* Degree (or equivalent) in Life Science, Engineering, or a related discipline.
* Minimum 3 years’ experience in a regulated medical device or life sciences environment.
* Strong knowledge of ISO 13485, ISO 14971, and regulatory requirements (FDA, MHRA, EU MDR).
* Proven experience with process validation, CAPA management, and QMS documentation.
* Practical understanding of Lean / Six Sigma tools and methodologies.
* Excellent communication, documentation, and analytical skills.
* A proactive, detail-oriented approach with the ability to manage multiple priorities in a fast-paced setting.
Seniority level
* Associate
Employment type
* Full-time
Job function
* Quality Assurance and Manufacturing
* Industries: Medical Equipment Manufacturing
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