Senior QA Medical Device Specialist — MDR/ISO Expertise

Ascendis Pharma

Hellerup

On-site

DKK 900,000 - 1,200,000

Full time

2 days ago

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Job summary

Ascendis Pharma in Hellerup, Denmark, seeks a Senior QA Medical Device Specialist to provide quality oversight across medical devices and drug-device combinations through the lifecycle. You will translate regulatory requirements into practical quality solutions, and collaborate with development, manufacturing, regulatory, commercial and external stakeholders to drive continuous improvement of the QMS.

Based in Hellerup, you will report to the Director of QA Medical Device and work with a global

Qualifications

Master's degree in engineering, pharmacy, biotechnology, life sciences or related field.
Minimum 7 years in the life science industry.
Experience with MDR, ISO 13485, FDA 21 CFR Part 820, ISO 14971.
Drug-device combination products exp. incl 21 CFR Part 4 & ISO 11608.
Hands-on QA and device development, including design controls.
Audits, inspections, supplier quality, and QA systems experience.
Professional proficiency in written and spoken English.

Responsibilities

Provide quality oversight of medical device and drug-device combinations across the lifecycle.
Support design controls, risk management, design reviews, and tech documentation.
Drive ongoing QMS improvement and implementation of regulatory changes.
Provide QA support for product release, deviations, CAPAs, changes, inspections and post-market activities.
Partner with cross-functional teams to translate regulatory requirements into practical quality solutions.