QA specialist

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Hillerød

Would you like to be part of an exciting medical device and combination products compliance journey supporting DMD (Device Manufacturing Development) and a multitude of stakeholders across Novo Nordisk? Do you have a strong quality mind-set and great interpersonal skills to make a difference within Quality Assurance? Then you need to apply for this fantastic opportunity. The position We are seeking a QA Compliance Specialist with an independent and innovative mindset, who excels in a dynamic and demanding regulatory environment. As part of our diverse QA department, you will be responsible for setting compliance direction, maintaining quality in signal handling, and providing compliance support across Novo Nordisk, including Product Supply and Device Delivery Solutions. The department oversees QA review and approval of various document types in processes within design control, validation, and release, to ensure compliance with current GMP guidelines and product quality. As the DMD QA representative and core group member for relevant focus groups, you will collaborate closely with stakeholders across Novo Nordisk to ensure the highest quality to patient in the implementation of new compliance signals from regulatory authorities. Additionally, as a major player in internal audits and external authority inspections, you will be expected to challenge responses and ensure compliance and learning within the organization. In the DMD QA department, you will also provide support for strategic initiatives, process improvement projects and relevant training as needed. We can offer you a great work environment with a collaborative atmosphere and opportunities to develop your competences further. Qualifications As our new Quality Assurance Compliance Specialist, the key requirements are:
  • You hold a Master’s degree in engineering, pharmacy or similar
  • You have min. 5 years of experience within cGMP for Medical device/Combination products +10 years of relevant experience within GMP
  • Deep understanding of Quality Management Systems
  • Extensive experience with: ISO13485, MDSAP, cGMP including 21CFR4 and 21CFR820, and EU Medical Device Regulation
  • Experience with cross organizational interaction
  • Proficiency in English, both written and oral
    • We are seeking an ambitious team player who is eager to help us improve our high standards. You are not afraid to challenge the status quo and take initiative to drive positive change, while also taking responsibility for your own learning and development. As a dedicated team player, you inspire trust and respect among colleagues and stakeholders alike. With our broad cooperation with many stakeholders, excellent collaboration and communication skills are essential. About the department At Device Manufacturing Development (DMD QA), we are a team of 27 highly qualified professionals based at our Hillerød site, with diverse backgrounds and interests. 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 Nordisk At Novo Nordisk, we are a life-science company dedicated to improving the lives of patients around the world. We offer a dynamic and international work environment, with opportunities for professional and personal development. Contact For further information, please contact Associate manager Carlos Gonçalves +45 3079 4194. Deadline Sunday the 8th of October You may submit your application in English or in Danish. 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.


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    Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

    Arbejdsstedet er beliggende i Hillerød.

    Jobbet er oprettet på vores service den 7.9.2023, men kan have været deaktiveret og genaktiveret igen.

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