Senior Supplier Assurance Engineer

Responsibilities

• Lead supplier qualification, approval, onboarding, and re-evaluation activities in compliance with regulatory requirements.
• Act as a Subject Matter Expert (SME) for supplier quality management processes.
• Manage supplier performance monitoring, including KPIs, trend analysis, and supplier scorecards.
• Collaborate with Procurement, Engineering, Manufacturing, and Supply Chain teams to ensure effective supplier controls.
• Support the Supplier Corrective Action Report (SCAR) process and supplier-related investigations.
• Assist with the oversight of outsourced processes and supplier-related change notifications.
• Support external regulatory inspections and audits, including FDA and Notified Body audits.
• Contribute to the development and continuous improvement of supplier quality SOPs and quality agreements.

Requirements

• Minimum 5 years of experience in the medical device industry.
• Significant experience in medical device Quality Assurance or Supplier Quality.
• Strong knowledge of ISO 13485 and EU MDR 2017/745.
• Demonstrated experience managing supplier quality systems and performance monitoring.
• Understanding of outsourced process controls and supplier risk management.
• Experience supporting regulatory inspections and external audits.
• University degree in Engineering, Bioscience, Life Sciences, Quality, or a related field.
• Ability and willingness to travel domestically and internationally for supplier visits.

Benefits

• Competitive compensation and comprehensive benefits.
• Healthcare and retirement plans.
• Support for work-life balance.
• Opportunities for ongoing professional development.

About the Company

OrganOx is a commercial stage organ technology company dedicated to developing technologies to improve outcomes for patients with acute or chronic organ failure. A pioneer in normothermic machine perfusion (NMP), OrganOx's flagship platform, the metra®, is used globally to keep donor organs in a metabolically active state, increasing the number of organs available for transplant. OrganOx is part of the Terumo Group.