Sr. Software Quality Assurance Engineer I

GROW WITH US:Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience. We’d love for you to team up with us to “innovate every day,” put “people first,” and take a “no-shortcuts” approach that has propelled us to become a leader in the diabetes technology industry.STAY AWESOME:Tandem Diabetes Care is proud to manufacture and sell the t:slim X2 insulin pump with Control-IQ technology. We’re also so much more than that. Our company’s human-centered approach to design, development, and support delivers innovative products and services for people who use insulin. Since many of our own team members live with type 1 diabetes, or have a loved one impacted by diabetes, the work is personal, and we are committed to the cause. Learn more at tandemdiabetes.com.A DAY IN THE LIFE:Come join our growing team! At Tandem, our Sr Software Quality Assurance Engineers are considered core team leaders who champion for process excellence throughout every stage of software development. Their expertise of FDA and international regulations are crucial to ensuring that our products are safe and effective.Please note that this role will not be responsible for any software development or testing.• Serves as a Quality representative on project core teams. Provides quality guidance throughout software development and maintains all quality-related deliverables.• Ensures quality integration into the overall functions of software development, scientific computation, and data acquisition.• Review/Approve various software lifecycle project deliverables based on procedural requirements.• Performs risk analysis and is responsible for risk management activities. Identifies, evaluates, and documents product risks. Coordinates risk-related updates with risk management team.• Provides traceability analysis and reports to ensure project requirements have been met• Participates on the Software Review Board (SRB) and Extended Software Review Board (ESRB) to evaluate and disposition software issues and Unresolved Anomalies.• Analyzes test results to ensure existing functionality and requirements are met, and if necessary, recommends corrective action.• Embraces the Design Control process by participating in design reviews and maintaining design history files.• Provides quality support and guidance for audits.YOU’RE AWESOME AT:• Knowledge of cloud or software-as-a-service (SAAS) strongly preferred.• Has working knowledge of FDA and international regulations, e.g. QSRs, ISO 14971, ISO 13485, IEC 62304.• Familiar with Good Documentation Practices (GDP).• Excellent written and verbal communication skills• Skilled at promoting team cooperation and a commitment to team success.• Adept at seeing change as an opportunity to improve business performance and campaigning for it when necessary.WHAT YOU'LL NEED:• Requires a bachelor's degree in Engineering or Computer Sciences or related field or equivalent combination of education and years of applicable experience.• 5 plus years’ experience serving as a Quality representative on project core teams in an FDA-regulated industry, including experience with conceptual design to market release.WHAT’S IN IT FOR YOU?In addition to innovative technology, we have a culture that fosters the idea that the happiest people are the most productive people. Not only do we hire forward-thinking achievers to join our workforce; we reward, develop, and retain them too. Just one of the many reasons of how we #StayAwesome! To learn more about our culture and benefits please visit https://www.tandemdiabetes.com/careers.BE YOU, WITH US!Tandem is firmly committed to being an equal opportunity employer and maintaining a diverse and inclusive environment. We value and embrace that every single one of us brings value to the table. But sometimes we forget that when we don’t meet 100% of a job description’s criteria – maybe you’re feeling that way right now? We encourage you to apply anyway. Because we want you to be you, with us.COMPENSATION & BENEFITS:The starting base pay range for this position is $95,000 - $120,000 annually. Base pay will vary based on job-related knowledge, skills, experience and may also fluctuate depending on candidate’s location and the overall job market. In addition to base pay, Tandem offers a competitive compensation package that includes bonus, equity, and a robust benefits package.Tandem offers health care benefits such as medical, dental, vision, health savings accounts and flexible saving accounts. You’ll also receive 11 paid holidays per year, a minimum of 20 days of paid time off (accrual starts on day 1) and have access to a 401k plan with company match. Learn more about Tandem’s benefits here!YOU SHOULD KNOW:Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable state and local Fair Chance laws and regulations. A conditional offer of employment from Tandem is contingent upon successful completion of a thorough screening process comprised of a drug test (excluding Marijuana) and background check, which includes a review of criminal history information.Tandem has good cause to conduct a review of criminal history information of candidates for this position, as this role may involve access to proprietary, sensitive and/or confidential information, including customer protected health information. This review is required to ensure that individuals in such roles uphold high standards of trust and integrity so as to protect the interests of our customers, employees, and stakeholders.If you are applying for this job and live in California, please read Tandem’s CCPA Notice: https://www.tandemdiabetes.com/careers/california-consumer-privacy-act-notice-for-job-applicants.REFERRALS:We love a good referral! If you know someone that would be a great fit for this position, please share!APPLICATION DEADLINE:The position will be posted until a final candidate is selected for the requisition or the requisition has a sufficient number of applications.#LI-KS1 #LI-Remote