We are seeking a detail‑oriented and proactive Quality Specialist – NCR / CAPA to support and strengthen our Non‑Conformance (NCR) and Corrective and Preventive Action (CAPA) processes. In this role, you will provide Quality Engineering expertise across investigations, root cause analysis, action planning, and effectiveness verification, ensuring our systems remain compliant with global medical device regulations.
You will collaborate closely with cross‑functional teams, act as a facilitator for NCR and CAPA activities, and contribute to a culture of continuous improvement, operational excellence, and regulatory compliance.

What You’ll Do
NCR & CAPA Process Ownership
•     Provide Quality Engineering support across all phases of NCR and CAPA activities, including containment, investigation, root cause analysis, action planning, and effectiveness checks.
•     Act as NCR and CAPA team owner/facilitator, ensuring timely progression and robust documentation.
•     Guide teams in implementing effective corrective and preventive actions.
•     Support development of verification tools to validate CAPA/NCR action plans.
•     Ensure appropriate containment actions are defined, communicated, and executed.
Compliance & Regulatory Alignment
•     Ensure processes comply with EU MDR, ISO 13485, FDA 21 CFR 820, MHLW Ordinance 169, and other global regulations.
•     Maintain management tools (trackers, electronic folders, etc.) to ensure audit readiness.
•     Participate in internal audits and support ongoing audit preparedness across the facility.
•     Work within the Quality Management System, ensuring accurate records and timely escalation of issues.
Data Analysis & Reporting
•     Generate and maintain trending data for NCR and CAPA processes, contributing to QMS KPI dashboards.
•     Provide trending reports and updates to senior management, functional leaders, regulatory authorities, and customers.
•     Present data and status updates to NCR and CAPA Review Boards.
•     Support dFMEA and pFMEA improvements in collaboration with the Risk Team, using NCR/CAPA insights.
Continuous Improvement & Collaboration
•     Develop new policies and procedures to enhance NCR/CAPA efficiency.
•     Build strong cross‑functional relationships to support effective investigations and quality improvements.
•     Contribute to departmental and facility objectives, promoting a culture of high performance and regulatory compliance.

Quality, Safety & Compliance Responsibilities
•     Work within company policies, the Quality Management System, and regulatory requirements at all times.
•     Maintain audit readiness across processes, documentation, and facility operations.
•     Ensure accurate record‑keeping and escalate quality concerns promptly.
•     Take responsibility for personal and team health and safety, and proactively highlight EHS issues.

What You’ll Bring
•     A relevant science or engineering degree (desirable) 
•     Six Sigma Green Belt (desirable).
•     Strong understanding of NCR, CAPA, root cause analysis, and trending methodologies.
•     Experience in a regulated industry, ideally medical device or pharmaceutical manufacturing.
•     Knowledge of Class III medical devices (desirable).
•     Working knowledge of Minitab or similar statistical tools (desirable).
•     Experience with FDA regulations and global medical device standards.
•     Strong analytical and problem‑solving skills, including use of statistical techniques.
•     Excellent facilitation, coordination, prioritisation, and communication skills.
•     Ability to manage multiple priorities and perform effectively under pressure.
•     Proficiency with Microsoft Office and the ability to learn new QA systems.