Senior Quality Assurance Specialist

About the role

The Senior Quality Assurance Specialist will ensure compliance with quality and regulatory requirements for our current and future product portfolio, starting with the flagship Class III injectable device JULÄINE. Reporting to the Senior QA Manager, you will work closely with cross‑functional teams across Quality, Regulatory Affairs, Manufacturing, Commercial, Clinical Affairs, and R&D.

Key responsibilities

• Develop, maintain, and continuously improve the Quality Management System (QMS) in line with ISO 13485, MDR, and MDSAP.
• Establish, monitor, and enhance quality processes throughout the organization.
• Create, review, and harmonise quality procedures, work instructions, and documentation.
• Oversee change‑control activities, ensuring proper assessment, implementation, and verification of effectiveness.
• Maintain traceability throughout the product lifecycle.
• Coordinate CAPA processes, ensuring timely investigation, implementation, and verification of corrective actions.
• Collaborate with Regulatory Affairs, Operations, and R&D to meet quality objectives.
• Support internal and external audits, drive follow‑up actions, and ensure inspection readiness.
• Monitor QMS performance via metrics, prepare management‑review inputs, and generate periodic quality reports.
• Develop and deliver training programmes on QMS processes and quality requirements.

Required profile

• Bachelor’s degree in life sciences, engineering, biomedical or a related field.
• Significant experience in quality assurance for medical devices, preferably Class III.
• Strong knowledge of regulatory frameworks (ISO 13485, MDR, MDSAP).
• Proven ability to work in a global, cross‑functional environment.

Required skills

• Quality Management System (QMS) implementation and maintenance.
• ISO 13485, MDR, MDSAP compliance.
• CAPA management.
• Change control processes.
• Traceability and documentation control.
• Audit preparation and execution.
• Quality metrics analysis and reporting.