Become a pivotal Subject Matter Expert (SME) in Supplier Quality for Medical Devices. This role demands extensive experience in the healthcare and life sciences sector, focusing on medical devices, IVD, and combination products. You will be the senior technical authority, driving excellence in supplier quality management, auditing, regulatory compliance, and QMS.

Your expertise will ensure suppliers adhere to critical standards like ISO 13485 and FDA requirements, safeguarding product quality and patient safety. This is an opportunity to shape and enhance supplier quality practices within a leading technology services organization.

Lead and execute comprehensive, risk-based supplier audits globally, covering contract manufacturers, sterilization providers, and laboratories. Evaluate supplier compliance with ISO 13485, FDA, EU MDR/IVDR, and other regulations. Oversee Supplier Corrective and Preventive Action (SCAPA) processes, drive root cause analysis, and ensure effective CAPA implementation. Qualify and manage suppliers based on risk assessments and maintain the Approved Supplier List. Develop and negotiate Quality Agreements (QTAs), monitor supplier performance via KPIs, and present findings to stakeholders.

Provide expert guidance on QMS, design controls, validation, and risk management. Serve as a key SME during regulatory inspections (FDA, Notified Bodies). Collaborate with cross-functional teams, mentor junior staff, and conduct internal training to elevate supplier quality standards and risk reduction initiatives.

A Bachelor's degree in a related scientific or technical field is essential, with an advanced degree being a strong preference. Possess 10+ years of progressive experience in Healthcare/Life Sciences, with at least 7 years dedicated to Supplier Quality Engineering, Auditing, QA, or Regulatory Compliance. A minimum of 5 years as a Lead Auditor for suppliers and contract manufacturers is required.

Demonstrated hands-on knowledge of ISO 13485, FDA QSR, and EU MDR/IVDR is crucial. Proficiency in CAPA/SCAPA, root-cause analysis, supplier qualification, risk assessment, QMS, design controls, and process validation is expected. Experience supporting FDA/Notified Body inspections and excellent technical documentation skills are vital. Strong communication, negotiation, and stakeholder management abilities are key for success in this role.