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 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). 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 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…