Quality 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 the "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 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. Learn more at tandemdiabetes.com

A DAY IN THE LIFE:

Quality Engineer I's at Tandem are also responsible for:

• 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.

WHEN & WHERE YOU'LL WORK:

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.

WHAT YOU'LL NEED:

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.

Minimum certifications/educational level:

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

Minimum experience:

• Six months previous experience.
• Experience working in a medical device, manufacturing or an FDA-regulated industry preferred.
• Experience in a GMP or ISO environment preferred.

COMPENSATION & BENEFITS:

The starting base pay range for this position is $72,800 to $91,100 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 and a robust benefits package.

Tandem offers health care benefits such as medical, dental, vision available your first day, as well as 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 (with accrual starting on day 1) and you will have access to a 401k plan with company match as well as an Employee Stock Purchase plan. 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 pre-employment 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.

SPONSORSHIP: Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

WHY YOU'LL LOVE WORKING HERE:
At Tandem, we believe joy fuels excellence. That's why we've built a workplace that celebrates your achievements and supports your well-being. Our team thrives on pushing boundaries and fostering growth, all while maintaining a spirit of fun and camaraderie. This is just one of the ways we stay awesome! Explore the benefits and reasons to love Tandem at https://www.tandemdiabetes.com/careers.

BE YOU, WITH US!

We embrace the value that every single one of us brings 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.

Tandem is firmly committed to being an equal opportunity employer and does not discriminate on the basis of age, disability, sex, race, religion or belief, gender identity or expression, marriage/civil partnership, pregnancy/maternity, or sexual orientation. We are an inclusive organization, and we welcome applications from a wide range of candidates. Selection for roles will be based on individual merit alone.

REFERRALS:
We love a good referral! If you know someone who 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.

Make a move that matters. Join Tandem Diabetes Care, where we're turning challenges into triumphs every day and where your talents will help shape a healthier, happier tomorrow.

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