Quality Assurance Associate II (Monday - Thursday, 2:30pm - 1:00am)

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 https://www.tandemdiabetes.com/

WHEN & WHERE YOU’LL WORK:

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

Schedule: This position has a schedule of Monday – Thursday, 2:30pm - 1:00am PST

A DAY IN THE LIFE:

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. 

Quality Assurance II’s at Tandem are also responsible for:

• 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.
• Ensures work is performed in compliance with company policies including Privacy/HIPAA and other regulatory, legal, and safety requirements.
• Performs other assignments or projects as directed

WHAT YOU’LL NEED:

Knowledge, skills & abilities:

• 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).

Minimum certifications/educational level:

• Associate’s degree or combination of education and applicable job experience.
• Bachelor’s degree preferred.

Minimum experience:

• 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.

PHYSICAL REQUIREMENTS:

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or b