Quality Assurance Associate (20170370)

Tandem Diabetes Care San Diego, CA
What you'll be doing:

You'll 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). You'll compile data for documentation of test procedures and may assist with report preparation. Other tasks include:

* Performs In-process, Final Inspection and Final Approval of Product :

* Reviews and approves manufacturing Device History Records (DHRs), associated test reports and records for compliance to specifications 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.

What you need for this position:

* 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.

* Associate's degree or combination of education and applicable job experience. Bachelor's degree preferred.

* 2-3 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.

Who we are:

Here at Tandem, Diabetes is all we do and we are dedicated to making the lives of people with diabetes better and better, through relentless innovation. "In Tandem" means together, and we strive to embody that in every aspect of our business. We believe that working in tandem, not in isolation, is the best way to continually exceed expectations.

Designed, assembled and supported from our San Diego, CA headquarters, we are the makers of the only color, touch-screen insulin pump that is capable of remote feature updates and compatibility with continuous glucose monitoring.

Read more about our company & culture here: https://www.tandemdiabetes.com/careers/life-at-tandem and see what our customers are saying here: #tsliminthewild

What's in it for you?

Stay well with us. Enjoy the outdoors during your workday by biking, running, or walking on one of our nearby trails.

Invest in your career. Tandem offers all employees access to training and development programs and courses to help keep your career and skillset updated, not outdated.

Celebrate in Tandem. Join in monthly employee get-togethers, tacos for Cinco de Mayo, corned beef for St. Patrick's Day, costume-contest for Halloween, and the annual JDRF

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