Quality Assurance Associate II; Temp

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 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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Quality Assurance Associates at Tandem perform 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.

A Quality Assurance Associate 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 3rd party audits.
• Confirms completion of required training plan before assuming job responsibilities.

On-Site:
This role is on-site four days a week at our San Diego office due to the nature of the work involved.

Schedule:

This position has a schedule of 2:30 pm - 1:00 am (PT)
Monday-Thursday
.

Please note that this a temporary position. As a temporary employee you will be employed through a staff agency partner. Benefits during your temporary assignment may be provided by the staffing agency. Access to Tandem sponsored benefits is contingent upon conversion from temporary to regular full-time status. Conversion is determined based on business need and job performance.

• Associate’s degree or combination of education and applicable job experience.
• Bachelor’s degree preferred.
• 5 plus years’ relevant quality and/or manufacturing experience in a FDA regulated industry, preferably medical devices
• Experience with…