Sr Quality Engineer I - Manufacturing

• 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:

An experienced team member in a manufacturing environment providing quality guidance and support for product launches, sustaining engineering, and quality system activities to assure conformance to established specifications and risk reduction. Works independently to optimize and continuously improve internal operations to meet department, business unit and company objectives. Also provides expertise and guidance to ensure quality systems are in place across the hardware development organization that improves quality of our devices as well as our business operations.

The Senior Quality Engineers at Tandem are also responsible for:

Serves as a Quality lead on sustaining engineering, production, and quality system activities.

Reviews and approves product and process changes/new designs to ensure they are developed, verified,

validated and documented in accordance with regulatory requirements.

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.

Analyzes and solves quality related problems with products and processes.

Provides input to IQ/OQ/PQ development for processes and equipment.

Supports the non-conforming material report (NCR) process and lead monitoring and tracking for open

NCRs and ensure timely closures.

Reviews and approves CO’s as well as provides quality input.

Provides quality input to Complaint, First Article, CAPA investigations.

Independently completes activities in Risk Analysis, Process Capability Analysis (Cpk),, Design Reviews,

Gage R&R, DOEs, V&V Testing, and reliability testing activities.

Facilitates or participates in cross-functional or cross-divisional process improvement teams to drive

product development quality excellence and cost savings initiatives.

Reviews and analyzes project and customer requirements, and assists project teams in tailoring and using

company procedures, methods, templates and tools.

Collects process metrics and lessons learned, reviews and evaluates processes and work products and

recommends improvements as appropriate.

Supports and leads, internal and external audits as scheduled to build the quality system and reduce risk.

Confirms completion of required training plan before assuming job responsibilities.

Ensures work is performed in compliance with company policies including Privacy/HIPAA and other

regulatory, legal, and safety requirements.

Other responsibilities as assigned.

WHEN & WHERE YOU’LL WORK:

This role is on-site five days a week at our Barnes Canyon office due to the nature of the work involved.

WHAT YOU’LL NEED:

• •Bachelor’s degree in a technical field, preferably Mechanical Engineering or the equivalent education and applicable work experience.
• •5 plus years experience working as a Quality Engineer in an FDA-regulated hardware development environment, medical device development, or an FDA-regulated industry.
• •Demonstrates proficient knowledge of Quality Engineering policies, principles and best practices.
• •Proficient knowledge of quality standards (ISO 13485, FDA QMSR, ISO 14971).
• •Proficiency with querying, navigating, and analyzing datasets
• •Understands the use of all test and quality measurement equipment.
• •Strong proficiency of statistical techniques including sampling theory, probability, capability analysis, and SPC.
• •Previous experience generating and analyzing quality metrics.
• •Demonstrated experience using problem solving methodologies: why-why analysis, fault tree analysis, cause and effect diagram etc.
• •Ability to work independently to identify potential quality issues and propose solutions.
• •Basic understanding of mechanical drawings & specifications including geometric dimensioning and tolerances (GD&T).
• •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 MiniTab and other applicable software packages.

EXTRA AWESOME:

Experience in a ISO environment preferred.

COMPENSATION & BENEFITS:

The starting base pay range for this position is $110K - $121K 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.

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.

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 sh