QA Medical Device Senior Manager

QA Medical Device Senior Manager

Ascendis Pharma

Hellerup, Denmark

We are seeking a passionate QA Medical Device Senior Manager to join our team. As a member of the Ascendis Pharma team, you will play a crucial role in the QA Medical Device team who is responsible for establishing relevant procedures for own activities as well as provide guidance and support to other functions, to ensure Ascendis has an effective QMS. The team participates in development projects and is also responsible for operational activities such as release of components and medical devices, managing suppliers including audits, plan and execute internal audits and regulatory intelligence.

The position is open to a candidate with a QA-mindset that find it attractive to have the opportunity to work with many aspects of device related activities from early development to life cycle management of drug-device combination products. 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, and report directly to Bolette Nordby, Director of QA Medical Device. You will be based in our Headquarters in Hellerup.

Your key responsibilities will be:

• QMS improvement activities;
• Taking a risk based approach and justify it;
• Support medical device/drug-device combination product development projects, design transfer and maintenance of technical documentation;
• Release of medical devices and components;
• Handle deviations, CAPAs, and change control cases;
• Assist in the approval of new suppliers;
• Assist during inspections and audits;
• Stay updated on relevant regulatory requirements such as standards and guidelines.

Qualifications and Skills:

You hold a Master’s degree or similar in natural science and has a minimum of 5 years QA experience in life science.

Furthermore, the preferred candidate has experience within the following areas:

• Experience with ISO13485:2016, MDSAP, 21CFR Part 820, 21CFR Part 4, ISO14971:2019, ISO11608:2022;
• Device development/design control;
• Managing QMS improvement activities;
• Supplier management;
• Lead auditor or experience with audits/inspection from NB/NCA preferably ISO13485;
• Injection pens, autoinjectors, SaMD/SiMD, connected health.

Key competencies:

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

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

• Critical thinking, yet pragmatic with a drive to find a solution;
• Clear and persistent in your communication, expectations, and requirements to quality;
• Thrive in an environment with many stakeholders;
• Cultural understanding;
• Proficiency in English at a professional level.

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Denmark      Medical Devices      Quality Assurance      Ascendis Pharma