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Ascendis Pharma, a global biopharmaceutical company, is seeking a Senior QA Medical Device Specialist to join its Quality Assurance team in Hellerup, Denmark. You will provide quality oversight across the lifecycle of medical devices and drug-device combination products, serving as a trusted quality partner to development, manufacturing, regulatory, commercial, and external stakeholders.
You will report directly to the Director of QA Medical Device and work within a team of 3 colleagues. Your role sits at the critical interface between medical devices and pharmaceuticals, translating regulatory requirements into pragmatic and compliant quality solutions.
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 and support continuous improvement of the Quality Management System and implementation of evolving regulatory requirements
- Provide quality support for product release, deviations, CAPAs, change controls, inspections, and post-market activities
- Act as a trusted QA business partner to cross-functional stakeholders by facilitating risk-based decision making and ensuring appropriate quality governance
The role involves minimal travel (1-5 days per year) and is based at Ascendis Pharma A/S, Tuborg Boulevard 12, Hellerup, Denmark.
Requirements:
- Relevant academic degree, preferably a master's degree in engineering, pharmacy, biotechnology, life sciences, or related scientific discipline
- Minimum 7 years of experience within the life science industry
- Extensive experience with MDR, ISO 13485, FDA 21 CFR Part 820, and ISO 14971
- Preferably experience with drug-device combination products, including 21 CFR Part 4 and ISO 11608
- Hands-on experience within Quality Assurance and medical device development, including design controls
- Experience supporting audits, inspections, supplier quality activities, and quality system processes
- Professional proficiency in written and spoken English
- Strong team player with analytical mindset and can-do attitude
- Entrepreneurial mindset and ability to thrive in informal, open environment where innovation and change are key
- Confident in interpreting regulatory requirements and translating them into operational practice
- Effective at building relationships and influencing stakeholders across development, manufacturing, quality, and regulatory functions
- Pragmatic, adaptable, and solution-oriented, with ability to balance compliance, quality, and business objectives
