Senior QA Medical Device Lead: Quality Partner Across Lifecycle

Ascendis Pharma A/S; Gentofte Kommune; À distance; DKK 900 000 - 1 200 000; Plein temps

Résumé du poste

Ascendis Pharma A/S in Denmark seeks a Senior QA Medical Device Specialist to oversee quality across drug-device products and collaborate with development, manufacturing, regulatory and external partners.

You will translate regulatory requirements into pragmatic quality solutions, support design controls, risk management, inspections, and post-market activities, and report to the Director of QA Medical Device.

Qualifications

• 7+ years of QA experience in the life sciences sector, focusing on medical devices and drug-device combos.
• Strong knowledge of MDR, ISO 13485, FDA 21 CFR Part 820, and ISO 14971.

Responsabilités

• Provide quality oversight of medical device and drug-device product activities across the lifecycle.
• Support development projects through design controls, risk management, design reviews, design transfer, and technical documentation maintenance.
• Drive and support continuous improvement of the Quality Management System and evolving regulatory requirements.
• Provide quality support for product release, deviations, CAPAs, change controls, inspections, and post-market activities.
• Act as a trusted QA partner to cross-functional stakeholders and facilitate risk-based decision making.

Connaissances

MDR/ISO13485

Regulatory interpretation

Quality Assurance

Formation

Master's degree in life sciences or engineering

Description du poste

Ascendis Pharma A/S in Denmark seeks a Senior QA Medical Device Specialist to oversee quality across drug-device products and collaborate with development, manufacturing, regulatory and external partners.

You will translate regulatory requirements into pragmatic quality solutions, support design controls, risk management, inspections, and post-market activities, and report to the Director of QA Medical Device.