Quality Expert in In-Vitro Diagnostics
15 hours ago
Job Description
The role of Quality Specialist with expertise within In-Vitro Diagnostics is a key position in the RDQ Operational Excellence department at Novo Nordisk A/S.
Key Responsibilities
- Ensure compliance with IVD regulations and other relevant requirements.
- Act as a Quality Partner and support key projects with IVD solutions.
- Collaborate with cross-functional teams and participate in strategic, cross-organizational projects.
- Expand organizational knowledge within the IVD medical device area.
- Provide QA support across Research & Development, including Quality Risk Management, Change Control, and Deviations.
Requirements
- A Master of Science degree within natural sciences (e.g., Pharmacy, Chemistry, Biology) with 6–8 years of experience in quality assurance, regulatory, or clinical affairs.
- Strong knowledge of regulatory requirements for IVD, including IVD regulations and relevant ISO standards, and their application to pharmaceutical IVD medical devices.
- Experience in maintaining a Quality Management System, participating in supplier qualifications, audits and inspections, and fluency in written and spoken English.
- Familiarity with project management and a 'can do' mindset to explore innovative ideas and new ways of working.
- Ability to set direction, propose compliant solutions aligned with business needs, and identify opportunities with a structured approach.
About the Department
The RDQ Operational Excellence department is committed to the continuous improvement and simplification of the Quality Management System (QMS).
Working at Novo Nordisk
At Novo Nordisk, we drive change and strive for excellence without fixating on perfection. We are a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future.
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