Senior QA Professional for Medical Devices

Job title:

Senior QA Professional for Medical Devices

Company:

Novo Nordisk

Job description

We may have the perfect role for you at QA for Device Manufacturing Development (FPMSAT QA) in Hillerød!Are you looking for an exciting opportunity to advance your career in Quality Assurance? If you’re passionate about ensuring regulatory compliance and advising your team on compliant solutions for medical devices, we want to hear from you! With your experience in product development and life cycle management, you’ll work alongside a team of passionate professionals to launch important medical devices to patients. Don’t miss out on this chance to take your career to the next level – apply now!The position
As our Senior QA professional, you will together with the QA team be responsible for delivering best-in-class Quality Assurance and work with our colleagues in Line-of-Business to ensure highest quality of our device products.

• 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.

We expect you to be able to handle situations independently, apply your subject matter knowledge, identify better practice, create improvements to processes, share knowledge and to let your colleagues learn and shine.Qualifications
To succeed in this role you should have:

• A 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.

Ready to lead and build strong relationships? Bring your excellent cooperation skills and flexible decision-making approach to our team. With an open-minded and positive attitude, you’re eager to make a difference and learn. If this sounds like you, but you don’t meet all the criteria, contact our hiring manager to see if you’re eligible!About the department
At Finished Product Manufacturing science and Technology (FPMSAT QA), we are a department of 42 highly qualified professionals based at our Hillerød site, with diverse backgrounds and interests. In team Product development QA we are 13 highly skilled professionals waiting for you to join us. We are responsible for ensuring the quality and compliance of all processes in Device Manufacturing Development (DMD), including product development and life cycle management, design control, testing, manufacturing development, and manufacturing processes. We take pride in our work and are constantly seeking to improve our competencies and processes through a focus on simplicity and collaboration. By joining our team, you will have the chance to make a real difference in the lives of patients through the development and life cycle management of crucial medical devices.Working at Novo NordiskAt Novo Nordisk, we don’t wait for change. We drive it. We’re 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. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development to manufacturing, marketing and sales – we’re all working to move the needle on patient care.Contact
For further information, please contact Qi Wei+45 34483549.Deadline
13 March 2025
We will review applications received on an ongoing basis, so do not hesitate to apply today.You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

Expected salary

Location

Hillerød, Hovedstaden

Job date

Fri, 28 Feb 2025 23:46:32 GMT

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