Senior QA Medical Device Specialist

Ascendis Pharma A/S; Gentofte Kommune; Remote; DKK 900.000 - 1.200.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

MDR/ISO13485

Regulatory interpretation

Quality Assurance

Ausbildung

Master's degree in life sciences or engineering

Jobbeschreibung

Are you passionate about working at the interface between medical devices and pharmaceuticals? Do you have significant experience navigating medical device quality requirements?

If so, now is your chance to join Ascendis Pharma as our new Senior QA Medical Device Specialist.

Ascendis Pharma is a global biopharmaceutical company committed to making a meaningful difference in patients’ lives. Guided by our core values of Patients, Science, and Passion, we are applying our innovative TransCon® technology platform to fulfill our mission of developing new therapies that demonstrate best-in-class potential to address unmet medical needs.

At our headquarters in Hellerup, Denmark, research facilities in Heidelberg, Germany, and additional offices across Europe and the United States, we are advancing programs in our Endocrinology Rare Disease and Oncology portfolios. We also collaborate with partners on the development of TransCon-based products in other therapeutic areas and markets.

We are seeking a passionate Senior QA Medical Device Specialist to join our growing team. As a key member of the Ascendis Pharma team, you will play a crucial role providing quality oversight across the lifecycle of medical devices and drug-device combination products while acting as a trusted quality partner to development, manufacturing, regulatory, commercial, and external stakeholders. Working at the interface between medical devices and pharmaceuticals, you will help translate regulatory requirements into pragmatic and compliant quality solutions. This is an exciting opportunity to work in a fast-paced environment, collaborate with cross-functional, global teams working together to achieve extraordinary results.

You will be joining the QA Medical Device team consisting of 3 colleagues, and report directly to Cecilie Bengtsen, Director of QA Medical Devicewho is based in Hellerup, Denmark. You will also be based in Hellerup, Denmark.

Your key responsibilities will be:

• 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.

Qualifications and Skills:

You hold a relevant academic degree – preferably a master’s degree in engineering, pharmacy, biotechnology, life sciences, or a related scientific discipline – and min 7 years of experience within the life science industry.

Furthermore, you have:

• 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.

Key competencies:

You are a strong team player, analytical, and have a can-do attitude.

You possess an entrepreneurial mindset and can thrive in an informal, open environment where innovation and change are key.

To succeed in this role, we also expect you to be:

• 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 the ability to balance compliance, quality, and business objectives.

Travel: 1-5 days per year.

Office: Ascendis Pharma A/S, Tuborg Boulevard 12, Hellerup, Denmark

Applications must be submitted in English and will be treated confidentially.

For more details about the position or the company, please contact Cecilie Bengtsen, Director of QA Medical Device [e-mail]

You can learn more about Ascendis by visiting our website www.ascendispharma.com