Senior Audit and Compliance Specialist

About the role

The Senior Audit & Compliance Specialist supports the Infectious Disease Business Unit by maintaining supplier audit programmes and ensuring continuous inspection readiness across the RMDx sites. This position reports to the Manager – Audits and Inspection Readiness and plays a key part in meeting regulatory requirements such as MDSAP and MDR/IVDR.

Key responsibilities

• Assist the RMDx Quality System to ensure audit programmes (supplier, internal, external) comply with corporate and external standards.
• Plan, execute and report supplier audits for RMDx sites, managing the audit schedule and metrics.
• Track and trend audit findings to identify systemic issues.
• Support ID sites with inspection‑readiness activities and host external inspections and corporate audits, including logistics and auditee coaching.
• Assist with aged CAPAs, complaint investigations and field actions related to inspections.
• Participate in quality‑system improvement initiatives and support regulatory submissions.
• Conduct full‑scope QMS audits of ID sites as required.

Required profile

• Level 8 degree in life sciences, engineering or a quality‑assurance related field.
• Minimum 5 years experience in a regulated manufacturing environment, preferably in quality.

Required skills

• MDSAP
• MDR / IVDR
• CAPA management
• Supplier audit execution
• Quality Management System (QMS) compliance

What we offer

• Opportunity to work within a global healthcare leader.
• Exposure to a broad portfolio of diagnostics, medical devices and nutrition products.
• Professional development in a highly regulated environment.