Quality Assurance Engineer - Software as a Medical Device

Imagine transforming the face of biomedical research, helping patients getting healthier with digital therapeutics, and advanced medical devices in a state-of-the-art research facility. That’s what we do at Novo Nordisk Research Center Seattle, Inc. (NNRCSI). Our scientists and engineers apply cutting-edge technologies to early R&D projects with the goal of bringing real change to People with Diabetes and Obesity. Such projects include applying data science when developing advanced medical devices and digital decision support solutions. At NNRCSI, your skills, dedication and ambition will help us change lives for the better. In exchange, we’ll offer you an opportunity to work with extraordinary talent, continuously learn and develop, and drive change to defeat diabetes and other serious chronic conditions.

The team is comprised of collaborative, diverse and passionate people who have a true sense of pride in their work and are committed to helping others grow and develop their careers. You’ll also have a platform to engage with key stakeholders on a global scale throughout the entire pipeline process. And while changing the future of diabetes and obesity treatment is no easy task, we also recognize the importance of an enjoyable workplace, which is why we’ve cultivated a culture of fun, ingenuity and innovation. And our competitive compensation package and support of a healthy work-life balance all add to a best-in-class employee experience. We are changing lives for a living. Are you ready to make a difference?

The Position
The US Device Research (USDR) SaMD Quality Assurance (QA) Engineer will contribute to realizing the USDR Digital Therapeutics vision to explore and develop new Software as Medical Device (SaMD) products that hold the potential to help patients within therapeutic areas covered by the Novo Nordisk corporate strategy.

Relationships
The SaMD QA Engineer reports to a Senior Manager in USDR or the Device R&D Quality Organization. Internal relationships include R&D colleagues within USDR and Device R&D colleagues in Denmark. This includes peer R&D Engineers, Data Scientists and Software Engineers. Other internal relationships include R&D QA colleagues in Denmark. External relationships may occasionally include commercial collaboration partners, academia and NNRCSI drug researchers.

Essential Functions

• Be QA coordinator in Digital Therapeutics/SaMD development projects
• Participate in project core team
• Ensure project deliverables for each development phase until completion
• Communicate and present quality project issues
• Review and approve development documents; e.g.: Requirements documents; Risk Management documents; Design verification documents; Design validation documents; Usability engineering documents; Input to submission file; Input to clinical documentation; Perform independent review of milestone endorsement documentation
• QA/ITQC for SaMD development projects; Ensure quality and compliance of SaMD; Perform required reviews and approvals throughout entire SaMD lifecycle process
• Approve the release of new or modified SaMD
• Ensure compliance with Quality Management System (QMS): Ensure that activities in USDR comply with NN QMS; Train and motivate colleagues in the right use of QMS
• Drive development of QMS: Ensure that QMS changes are coordinated and executed in compliance; Review changes to QMS; Drive QMS improvement activities
• Regulatory Requirements: Up to date on current quality system regulation requirements from EU and US: ISO13485, 21CFR820, and 21CFR part 4 to ensure compliance in QMS and project documentation; Familiar with 21CFR11 Electronic Records/Electronic Signatures; Familiar with EU and US Classification of medical devices and combination products in order to select the correct quality system requirements for compliance and regulatory approval; Familiar with SaMD standards and guidance; e.g. IEC82304-1, IEC62304
• Train USDR employees in Quality, Compliance and QMS elements
• QA review of Deviations
• QA review of Change Requests
• Lead audits and inspections
• Communication: Able to explain facts, practices, policies, etc. to others within or outside of the organization. Occasionally need to convince others with mutual interests to accept new concepts, practices, and approaches; Drive technical collaboration; Hand over QA responsibility from USDR to DH-IT; Coordinate QA tasks for clinical trial projects; Comment on standard operating procedures (SOP) updates
• Identify, specify, and drive activities for competency development

Physical Requirements
Approximately 10% overnight travel

Qualifications

• Bachelor’s degree required. 
• 7+ years of relevant experience required
  • Relevant experience includes but not limited to: QA of medical devices, SaMD, or other pharmaceutical products
• Demonstrated skills within several of the following fields preferred: Experience within Quality Assurance of Medical Devices; Knowledge of 21CFR820, ISO13485, ISO11608; Development of medical devices; SW design knowledge
• Excellent written and oral communication skills
• Ability to influence, communicate and collaborate across the local organization

Novo Nordisk is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.