Quality Assurance Associate II

Tandem Diabetes Care

2d • $23 - $24 • Onsite

About The Position

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 tandemdiabetes.com 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. QAAIIs at Tandem are also responsible for: (Shift; Fri/Sat/Sun 5am - 530pm pst on-site.) 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.

Requirements

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

Nice To Haves

• Bachelor’s degree preferred.

Responsibilities

• 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.

Benefits

• Tandem offers health care benefits such as medical, dental, vision available your first day, as well as 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 (with accrual starting on day 1) and you will have access to a 401k plan with company match as well as an Employee Stock Purchase plan.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree
• Number of Employees: 501-1,000 employees