Senior SaMD QA Advisor
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Søborg
- Quality
- Søborg
Title: Senior QA Advisor
Department: Digital Health & Staffs Quality
Job location: Søborg / Denmark
Do you want to break new ground? Do you want to deliver innovative digital solutions to patients worldwide? Digital Health develops digital therapeutics and solutions for people living with Diabetes and other chronic diseases. We are searching for a Senior QA Advisor within Medical Device Design Control and Digital Health med drive/PM/coordinator who loves to drive solutions
About the department
Digital Health is a new and exciting area that delivers innovative digital solutions which will supplement Novo Nordisk’s drug offerings and are a prioritized strategic focus area for Novo Nordisk. Digital Health & Staffs Quality is responsible for quality assurance in this area.
Our newly established QA team - consisting of 9 employees - is working closely together with multiple stakeholders e.g. Digital Health IT and various Digital Health business units in Novo Nordisk a/s to develop new digital products. Our products are developed through new agile ways of working and in close collaboration with vendors and partners. The area is new to the industry, regulators, and Novo Nordisk and it is therefore highly prioritized that we provide new ideas, competencies, and drive innovative solutions, and perspectives in order to succeed on our journey.
We also act as Novo Nordisk Software as a Medical Device Competency Centre. For inspiration https://novonordisk.sharepoint.com/sites/DigitalHealthStaffsQuality
The position
You will as a Senior QA Advisor act as Business Partner supporting the organisation by developing and optimising quality related processes. You will ensure compliance for Digital Health solutions throughout their lifecycle from development through operations to retirement. You will work with many stakeholders and be exposed to many different business areas throughout Novo Nordisk, in Denmark and globally.
- In our role as SaMD Competency Center you are responsible for:
- Driving and optimising new and existing cross-organisational processes and systems together with our stakeholders
- Communicating, advising, training and knowledge-sharing with Digital Health Business Units across Novo Nordisk
- Reviewing and approving key quality documents, releasing Digital Health products to the market and participating in audits and inspections.
Qualifications
You will hold the following qualifications:
- Strong drive, coordinator, PM, thrives in an agile setting, and have a can-do mindset
- Good stakeholder and communication skills
- A Master's degree, engineer, quality background, IT or similar
- Ideally + 5 years of experience in Medical Device Design Control and IT software engineering.
- Knowledge of regulatory requirements related to Medical Devices and how they apply to software-based products
- Experience with maintaining a Quality Management System and certificates.
- Fluency in English (oral and written) is a prerequisite.
Deadline
1 of December 2020
Contact
For further information, please contact Director, Tine Andersen at [email protected] or +4530757671
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 chronic 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 12.11.2020, 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.
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