Quality Engineer

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 the “no-shortcuts” approach that has propelled us to become a leader in the diabetes technology industry.

Tandem Diabetes Care is proud to manufacture and sell the Tandem Mobi system and t:slim X2 insulin pump with Control-IQ+ technology — an advanced predictive algorithm that automates insulin delivery. But we’re 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. Because many of our own team members live with diabetes, or have a loved one impacted by diabetes, the work is personal, and we are committed to the cause.

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Responsible for providing quality guidance and support for product launch, sustaining engineering, production and quality system activities to assure conformance to established specifications. Facilitates the optimization and continuous improvement of internal operations to meet department, business unit and company objectives.

• Serves as a Quality representative on product launch and sustaining engineering project teams.
• Assures all actions required to optimize the quality, manage the risk, and maintain the compliance of all products, planned and completed, and that the results drive quality and quality system actions.
• Reviews quality related problems with products and processes; provides input on problem resolutions.
• Provides input and contributes content to IQ/OQ/PQ development for processes and equipment.
• Reviews and approves ECO’s as well as provides quality input to support closure (QMS updates, Procedural changes, etc.).
• Provides quality input to Complaint, FA, CAPA investigations and executes corrective actions when applicable.
• Participates in activities such as Risk Analysis, Process Capability Analysis (Cpk), Gage R&R, DOEs, and V&V Testing.
• Participates on cross-functional or cross-divisional process improvement teams to drive operational quality excellence and cost savings initiatives.
• Collects process metrics and lessons learned, reviews and evaluates processes and work products and recommends improvements as appropriate.
• Confirms completion of required training plan before assuming job responsibilities.
• Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.
• Other responsibilities as assigned.

Onsite: This position is fully onsite at our facility in San Diego, California. Equipment for the role will be provided and training will occur onsite.

Schedule: This position will work Monday - Friday from 8:00 AM - 5:00 PM PST or equivalent based on time zone.

Knowledge, skills & abilities:

• Demonstrates intermediate knowledge of Quality Engineering principles and best practices.
• Knowledge of principles outlined in Good Manufacturing Processes (GMP).
• Understands the use of test and measurement equipment, e.g. optical comparator, and other inspection equipment, data acquisition, pressure, temperature meters, and mechanical measurement tools.
• Capable of using statistical techniques: probability, capability, and SPC.
• Able to recognize non-conformances from accepted and documented practices.
• Able to assert own ideas and persuade others through effectively consolidating, evaluating, and presenting relevant information.
• 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.
• Ability to effectively use MS Office suite (Word, Excel, Outlook) and other applicable software packages.

• Bachelor’s degree in Engineering, preferably Mechanical Engineering or the equivalent education and applicable work experience.

• Six months previous experience.
• Experience…