Software as a Medical Device (SaMD) Senior QA Advisor
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Søborg
- Quality
- Søborg
Do you want to break new ground? Do you want to deliver innovative digital solutions to 29.000.000 patients worldwide? Digital Health develops digital therapeutics and solutions for people living with Diabetes and other chronic diseases. We are searching for a Software as a Medical Device (SaMD) Senior QA Advisor with Medical Device Design Control, Software and QA experience to support Novo Nordisk in this journey.
Digital Health is a new and exciting area delivering innovative digital solutions which will supplement Novo Nordisk’s drug offerings. Our QA team is working closely together with the Digital Health business unit to develop new digital products to enable new ways of interacting with patients. Furthermore, we are working closely together with the Digital Health IT unit working with mobile and emerging technology and cloud offerings.
The products are developed through new agile ways of working and in close collaboration with vendors and partners. You will as a “Quality Business Partner” support the organisation in ensuring that Quality supports the business incl. compliant processes and products.
About the department
Digital Health & Staffs Quality is responsible for quality assurance in Novo Nordisk’s Staff Areas incl. Digital Health. Digital Health products are a prioritized strategic focus area for Novo Nordisk. We are a newly established team with high management focus and responsible for an area new to the industry, regulators, and Novo Nordisk why we need to provide new ideas, competencies, solutions, and perspectives in order to succeed on our journey.
The team consists of 7 employees – all very ambitious, highly skilled and very experienced. In the team we are working hard on supporting Novo Nordisk Digital Health aspiration, sharing knowledge and learnings internally and across Novo Nordisk - while also having fun. A group of external consultants are supporting us.
We work closely together with the Digital Health, Digital Health IT and Device R&D business units as well as with our external suppliers and partners to bring the best and compliant innovative solutions to market for our patients.
The position
In your role as SaMD Senior QA Advisor you will ensure compliance for Digital Health solutions throughout their life-cycle from development through operations to retirement. This includes review and approve key quality documents, release Digital Health products to the market and participate in audits and inspections.
As SaMD products are new to Novo Nordisk, you will take part in collaborating, training, communicating, and knowledge-sharing with organisation across Novo Nordisk. Thereby, you will be exposed to many different business areas throughout Novo Nordisk both in Denmark and globally.
As we are a newly established team, you are expected to take part in the development of the department, being proactive in identifying better practices and bring continuous improvements to the area. You will also participate in cross-organisational projects e.g. ensuring compliance while working Agile.
The position is based in Søborg and you should expect ca. 10 days of travel per year. Since you will collaborate with colleagues across the globe, you must expect some virtual meetings to take place outside normal DK working hours.
Qualifications
You have a Master's degree within a relevant field and a proven track record with 5-7 years’ experience in Medical Device Design Control and/or IT/software engineering. You have a strong knowledge of regulatory requirements related to Medical Devices and how they apply to software-based products - and/or IT/software engineering
You are familiar with maintaining a Quality Management System and certificates.
You have worked with an innovation agenda and have a ‘can do’ mind-set, which is required to explore new ideas and ways of working. You are known for your ability to set direction, suggest compliant solutions supporting business needs, your structured approach and to spot improvement opportunities. Your excellent communication and stakeholder management skills enables you to liaise at all levels of the organisation, in different geographies and from diverse cultures.
To succeed in this role, it is crucial that you thrive with working independently as well as part of a team. In addition, you must have strong work ethics and willingness to take responsibility and drive success.
Fluency in English (oral and written) is a prerequisite.
Working at Novo Nordisk
At Novo Nordisk, we have been changing diabetes since 1923. If you are ready to strengthen our position as an innovative pioneer and respected industry leader, we encourage you to join us to make the most of your talent.
Contact
For further information, please contact Tine Andersen at +45 3075 7671.
Deadline
22 March 2020. Interviews will be conducted continuously. Please submit your application online including motivational letter and CV in English.
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 "Afdelingsleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 6.3.2020, 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.
- Afdelingsleder
- Søborg
- Søndag den 22. marts 2020
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