We are seeking an experienced and proactive Senior Quality Engineer – Internal Quality Audits & Training to play a key role in ensuring our Quality Management System remains fully compliant, effective, and audit‑ready at all times.
In this position, you will lead the Internal Quality Audit Programme, coordinate external regulatory audits, and deliver high‑quality training to support compliance with global medical device regulations. You will act as a trusted advisor on quality matters, supporting both departmental and facility‑wide objectives. This is a highly visible role that interacts with teams across the organisation and contributes directly to maintaining our culture of quality, continuous improvement, and regulatory excellence.
What You’ll Do
Internal & External Audit Leadership
• Manage and coordinate the Internal Quality Audit Programme, performing audits according to schedule.
• Lead preparation activities for external regulatory inspections and Terumo Corporate audits.
• Develop and maintain processes for managing unannounced audits.
• Respond to audit findings, track actions through to closure, and ensure ongoing audit readiness.
• Coordinate corrective actions and verify effectiveness for audit‑related and manufacturing issues.
Quality Systems & Compliance
• Ensure processes and procedures comply with EU MDR, ISO, CFR Part, MDSAP, and other applicable regulations.
• Support management of corporate quality requirements including TGQPs, Shoki Ryudo, QAL, and SQPGs.
• Analyse quality data trends and support preparation of materials for Quality Management Review.
• Maintain up‑to‑date cGMP/GDP training materials and deliver QMS training, including FDA readiness.
Training & Continuous Improvement
• Develop and deliver training on key regulatory and QMS requirements (ISO, CFR, MDSAP, MDR).
• Promote a culture of high performance, continuous improvement, and regulatory compliance.
• Provide expert consultation on quality topics to support business and departmental objectives.
• Compile quality metrics and enhance the audit programme based on data‑driven insights.
Cross‑Functional Collaboration
• Work closely with teams across the facility to ensure alignment with quality and regulatory expectations.
• Interpret technical information from multiple sources and communicate requirements clearly.
• Track internal audit actions and ensure timely closure.
• Support CAPA, NCR, complaints, and risk management processes, including effectiveness checks.
Quality, Safety & Compliance Responsibilities
• Work within company policies, the Quality Management System, and regulatory requirements at all times.
• Ensure accurate record‑keeping and escalate quality concerns promptly.
• Maintain facility, processes, and documentation in a constant state of audit readiness.
• Take responsibility for personal and team health and safety, and proactively highlight EHS concerns.
What You’ll Bring
• A relevant Science or Engineering degree (or equivalent experience).
• Proven experience in Quality Management Systems within a medical device or similarly regulated environment.
• Lead Auditor or Internal Auditor qualification with demonstrable audit experience.
• Strong analytical and problem‑solving skills.
• Knowledge and experience with FDA regulations, MDSAP, and MDR.
• Thorough understanding of global medical device regulations and QMS requirements.
• Excellent communication, facilitation, coordination, and prioritisation skills.
• Ability to manage multiple priorities and perform effectively under pressure.
• Strong IT skills, including Microsoft Office and the ability to learn new QA systems.