QA Medical Device Senior Manager
1 month ago
We are seeking a highly skilled and experienced QA Medical Device Senior Manager to join our team at Ascendis Pharma. As a key member of our QA organization, you will play a crucial role in ensuring the quality and compliance of our medical devices and drug-device combination products.
Key Responsibilities- Develop and implement QMS improvement activities to ensure compliance with regulatory requirements
- Support medical device and drug-device combination product development projects, including design transfer and maintenance of technical documentation
- Release medical devices and components, and handle deviations, CAPAs, and change control cases
- Assist in the approval of new suppliers and participate in audits and inspections
- Stay up-to-date on relevant regulatory requirements, including ISO13485:2016, MDSAP, 21CFR Part 820, and ISO14971:2019
- Master's degree in a natural science or a related field
- Minimum 5 years of QA experience in life science, with a focus on medical devices
- Experience with ISO13485:2016, MDSAP, 21CFR Part 820, and ISO14971:2019
- Strong analytical and problem-solving skills, with a can-do attitude and a drive to find solutions
- Excellent communication and interpersonal skills, with the ability to thrive in a fast-paced environment
As a QA Medical Device Senior Manager at Ascendis Pharma, you will have the opportunity to work in a dynamic and innovative environment, collaborating with cross-functional teams to achieve extraordinary results. You will be part of an expanding QA organization, supporting development, clinical, commercial, and launch activities. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.
Travel: 5-10 days per year.
Office: Ascendis Pharma A/S, Tuborg Boulevard 12, Hellerup, Denmark.
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