Senior Quality Assurance Professional for Medical Devices

Category: Quality

Location:Hillerød, Capital Region of Denmark, DK

• You will be responsible for setting the compliance direction within development projects, during submission and launching to markets world-wide, when we transfer our devices from development to production and during life cycle management of Novo Nordisk’s device products portfolio.
• You will get an impact on a broad range of the crucial processes to deliver products to our patients.
• You will find solutions through a solid process and business understanding and give proactive advice to our stakeholders to secure we establish simple compliant solutions within processes such as: Design Control, Risk Management, and testing.
• You will play an important role in ensuring that we build competent skills in Quality Assurance and have an in-depth understanding of relevant regulatory requirements.

• Master's degree in Technology, Engineering, Pharmacy, Chemistry, or a related field.
• Extensive experience from the pharmaceutical industry either from production, QA, or QC where you have gained a solid and up-to-date knowledge of quality and GMP requirements i.e. Validation, Non-Conformity, Corrective and Preventive Actions, Change Control and Complaints.
• Experience with medical devices Design Control, regulations and standards is a bonus.
• Experience with connected medical devices, combination products and needle-based automated injection systems is an advantage.