Senior QA Medical Device Specialist

About the role

Join Ascendis Pharma as a Senior QA Medical Device Specialist, providing quality oversight across the lifecycle of medical devices and drug‑device combination products. You will act as a trusted quality partner to development, manufacturing, regulatory, commercial and external stakeholders.

Key responsibilities

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

Required profile

• Relevant academic degree (preferably master’s) in engineering, pharmacy, biotechnology, life sciences or related field.
• Minimum 7 years of experience in the life‑science industry.
• Strong analytical, team‑player attitude with an entrepreneurial mindset.

Required skills

• Extensive experience with MDR, ISO 13485, FDA 21 CFR Part 820 and ISO 14971.
• Experience with drug‑device combination products, including 21 CFR Part 4 and ISO 11608.
• Hands‑on quality assurance experience in medical device development, including design controls.
• Experience supporting audits, inspections, supplier quality activities and quality system processes.
• Professional proficiency in written and spoken English.