Systems Quality Engineer

Engineer, Quality Systems

West Yorkshire, UK (on-site)

Walker Cole International is partnering with a Class III (implantable) medical device manufacturer to find their new Engineer, Quality Systems. Reporting to the UK Head of Quality, you'll drive the development, measurement and continual improvement of sub processes supporting the global QMS, while providing direct, on-the-floor quality engineering support to production for devices manufactured in compliance with ISO 13485 and 21 CFR 820.

What you'll be doing:

Quality Systems

• Own global QMS performance KPIs and metrics, delivering statistically driven analysis, leadership reporting on risks and actions, and routine input to management review.
• Own the global non-conformance analysis system, determining escalation to CAPA, HHE and FSCA, and lead NCRs, CAPA, quality plans or projects for underperforming sub processes.
• Ensure QMS documentation is accurately filed, scanned, indexed and maintained, acting as primary point of contact for document retrieval.
• Conduct first and second party audits and support third party audits, ensuring findings are assessed, escalated and managed according to severity and risk.
• Establish and deliver training on core QMS systems, processes and procedures.

Production Quality Support

• Act as the on-floor quality point of contact, providing real-time guidance on quality system requirements, non-conformances and deviations.
• Investigate and disposition non-conforming material and participate in MRB activities in line with ISO 14971 risk management principles.
• Support line clearance and inspection activities, ensuring DMR compliance and DHR completeness, accuracy and traceability (including UDI) prior to release.
• Review and approve production deviations, temporary changes and engineering/document change requests.
• Support root cause investigation and corrective/preventive action for production non-conformances and trends.
• Author and maintain production quality procedures, work instructions and inspection criteria, and deliver GMP and quality system training to production personnel.
• Provide quality oversight for process, equipment and software validation and participate in routine production quality reviews.

What we're looking for:

• Bachelor's degree in an associated field, appropriate quality certification, or 3-5 years' experience in quality systems within medical device or a highly regulated industry.
• Working knowledge of 21 CFR 820, EU MDR and ISO 13485, with awareness of design control (21 CFR 820.30) and risk management (ISO 14971) for Class III / implantable devices.
• Lead auditor certification, supplier auditing experience and production support experience (NC disposition, MRB, DHR review) are highly desirable.
• High integrity and attention to detail, with strong project, stakeholder management and problem-solving skills.
• Sound, risk-based decision-making and the ability to work independently within timelines.
• Comfortable on the production floor and able to work in a cleanroom in full gowning, following strict safety and contamination control protocols.

Quality Systems | QMS | Medical Devices | Class III | ISO 13485 | 21 CFR 820 | EU MDR | ISO 14971 | CAPA | MRB | DHR | Auditing | GMP