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:

This role will be 1st shift; Monday - Thursday, 4am - 230pm.

Performs inspection and release of manufacturing goods during the manufacturing process by conducting routine and non-routine verification and review of in-process and finished products under general supervision and according to Quality Test Procedures (QTP) & Standard Operation Procedures (SOPs). Compiles data for documentation of test procedures and may assist with report preparation. 

YOU’RE AWESOME AT:

• Performs In-process, Final Inspection and Final Approval of Product :
  • Reviews and approves manufacturing Design History Records (DHRs), associated test reports and records and reports abnormalities.
  • Verifies training and other records for compliance to specifications.
  • Assists with resolving non-conformances occurring with in-process and finished products.
  • Provides quality oversight of manufacturing process/final packaging.
  • Updates departmental spreadsheets and statistics.
  • Assists in revising DHR’s, work instructions, SOP’s, process risk documents, etc.
  • Maintains department documentation and inventory of retained materials.
  • Reviews and approves manufacturing records such as test reports and 5S log-sheets.
  • Assists with calibration/preventive maintenance (PM) program:
    • Checks PM logbooks on manufacturing equipment for completeness and accuracy.
    • Verifies area equipment is within calibration specifications.
• May assist with Incoming Inspections as required.
• Assists with Internal audits and participates in 3^rd party audits.
• 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.

EXTRA AWESOME:

• Associate’s degree or combination of education and applicable job experience, Bachelor’s degree preferred.
• 5 years of relevant quality and/or manufacturing experience in a FDA regulated industry, preferably medical devices.
• Experience with QSRs, QC testing methods and general knowledge of GMP requirements for production.
• Experience with lot release, document review, and in-process inspection.
• Deep understanding of GMP regulations and Process Controls, including document review, in-process and final acceptance criteria, identification and traceability requirements, and segregation of materials.
• Able to effectively share information and ideas within and outside of department in written or verbal form; able to put forth own ideas and gain understanding from others.
• Proficient at supporting effective interactions between team members and among cross-functional teams.
• Demonstrated ability to schedule and coordinate project priorities and resources and to produce high quality work.
• Proficient experience with MS Office suite (Word, Excel, Outlook).

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 $19.50 - $24.00 per hour. 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 (starting in year 1) and have access to a 401k plan with company match. Learn more about Tandem’s benefits here!

YOU SHOULD KNOW:

Potential new employees must successfully complete a drug screen (excludes marijuana) and background check which includes criminal search, education certification and employment verification prior to hire. 

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.

The position will be posted until a final candidate is selected for the requisition or the requisition has a sufficient number of applications.

REFERRALS:

We love a good referral! If you know someone that would be a great fit for this position, please share!

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.

#LI-Onsite #LI-DW1