QA Compliance Specialist for Medical Devices
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Hillerød
- Quality
- Hillerød
Do you have a strong background and knowledge about GMP requirements related to medical device and combination products? Do you also have practical experience from working with design control processes and/or regulatory processes related to medical devices? And do you thrive in understanding regulatory requirements, sharing your professional insights and have the communication skills to function as a source of knowledge for a host of dedicated colleagues across the organisation? Then you might be the person we are looking for in Device Manufacturing Development QA (DMD QA) in Hillerød.
About the department
In DMD QA we are 26 highly qualified employees. We are responsible for assuring quality and compliance of all processes in Device Manufacturing Development (DMD). This includes design control, manufacturing development and manufacturing processes. Both internally in DMD and in the rest of Novo Nordisk we have many key stakeholders due to the nature of the processes in DMD. We are constantly improving our competences and our way of working by focusing on simplicity, agility and collaboration for us to be able to deliver the best possible support to the business.
The position
As our QA Compliance specialist your main task will be to support employees in DMD in understanding the regulatory requirements. You are expected to support the translation of these requirements in the simplest way into our processes and thereby ensure compliance with the applicable regulations, standards and guidelines.
Your compliance expertise will also be used across the many organisational units in Novo Nordisk working within the device area. You will be member of Novo Nordisk Device Development Group and have a key role when new requirements are translated into Novo Nordisk Quality Management System. You will also have a key role in audits and inspections in DMD, being the expert that can coach our employees when needed.
In DMDQA we expect you to train and coach your colleagues, for them to grow with respect, to understand the regulatory requirements. We expect you to act as a role model when giving support and compliance advice in the organisation.
In other words, you will be quite visible in the organisation, being the specialist that colleagues and management will rely on when having a need for understanding regulatory requirements. You will have a broad stakeholder landscape to navigate in, - both across the quality organisation in Novo Nordisk and also within DMD and the important collaboration partners in Device Research and Development and Regulatory Affairs.
Qualifications
You have a master’s degree within engineering, pharmacy or similar and minimum 5-10 years of experience from the medical device industry.
You are ready to take on responsibility and you convey your knowledge and experience with a steady hand. We expect you to build trustful relations across the organisation and to competently enjoy being the expert your colleagues can count on for advice and sparring. You use your excellent cooperation skills when you manage your stakeholders, both in- and externally to ensure reaching solutions will meet both requirements and stakeholder interests. You are seen as well-organised, independent and have a flexible but firm approach.
You are attracted by the opportunity to use your quality skills in a highly complex and ever-changing working environment. As we work in a global business environment, we expect you to be proficient in English, in speech as well as in writing.
Working at Novo Nordisk
At Novo Nordisk, you will help millions of people who are living with diabetes. We expect high performance and the ambition to make your mark on our business. In exchange, we offer a wide range of opportunities for professional and personal development.
Contact
For further information, please contact Inger Sørensen at +45 3075 4648.
Deadline
07 June 2020.
Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.
Information og data
Denne ledige stilling har jobtypen "Finansmedarbejder", og befinder sig i kategorien "Økonomi og jura".
Arbejdsstedet er beliggende i Hillerød.
Jobbet er oprettet på vores service den 15.5.2020, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Finansmedarbejder
- Hillerød
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