QA Medical Device Senior Manager

1 month ago


Hellerup, Gentofte Kommune, Denmark Ascendis Pharma Full time
About the Role

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
Requirements
  • 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
What We Offer

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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