Quality Assurance Associate II (Temp to Hire)

Tandem Diabetes Care; San Diego (CA); On-site; USD 30,000 - 33,000; Full time

Job summary

Tandem Diabetes Care is seeking a Quality Assurance Associate for on-site manufacturing QA in San Diego. The role conducts inspection and release of goods during manufacturing according to QTPs & SOPs, compiling data for test documentation and supporting report preparation.

The position is temporary, with benefits during the assignment and potential for conversion. Minimum A.S. degree plus 5+ years in QA/manufacturing in a FDA-regulated setting are required.

Qualifications

• Associate’s degree or combination of education and applicable job experience.
• Bachelor’s degree preferred.
• 5+ 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.
• Proficient at supporting effective interactions between team members and among cross-functional teams.
• Proficient experience with MS Office suite (Word, Excel, Outlook).

Responsibilities

• 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.

Skills

Quality & manufacturing experience

GMP knowledge

QC testing

QSRs

Document review

In-process inspection

Project coordination

Communication

Cross-functional collaboration

MS Office

Education

Associate’s degree

Bachelor’s degree preferred

Job description

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:

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.

WHEN & WHERE YOU’LL WORK:

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.

WHAT YOU’LL NEED:

• 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 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).

COMPENSATION & BENEFITS:

The starting base pay range for this position is $22.50 - $24.00 per hour. Base pay will vary based on job-related knowledge, skills, experience and may also fluctuate depending on candidate’s location and the overall job market. In addition to base pay, Tandem offers a competitive compensation package that includes bonus and a robust benefits package.

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. Learn more about Tandem’s benefits here!

YOU SHOULD KNOW:

Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable state and local Fair Chance laws and regulations. A conditional offer of employment from Tandem is contingent upon successful completion of a pre-employment screening process comprised of a drug test (excluding marijuana) and background check, which includes a review of criminal history information.

Tandem has good cause to conduct a review of criminal history information of candidates for this position, as this role may involve access to proprietary, sensitive and/or confidential information, including customer protected health information. This review is required to ensure that individuals in such roles uphold high standards of trust and integrity so as to protect the interests of our customers, employees, and stakeholders.

SPONSORSHIP:

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

WHY YOU’LL LOVE WORKING HERE:

At Tandem, we believe joy fuels excellence. That’s why we’ve built a workplace that celebrates your achievements and supports your well-being. Our team thrives on pushing boundaries and fostering growth, all while maintaining a spirit of fun and camaraderie. This is just one of the ways we stay awesome! Explore the benefits and reasons to love Tandem at https://www.tandemdiabetes.com/careers.

BE YOU, WITH US!

We embrace the value that every single one of us brings to the table. But sometimes we forget that when we don’t meet 100% of a job description’s criteria – maybe you’re feeling that way right now? We encourage you to apply anyway. Because we want you to be you, with us.

REFERRALS:

We love a good referral! If you know someone who would be a great fit for this position, please share!

APPLICATION DEADLINE:

The position will be posted until a final candidate is selected for the requisition or the requisition has a sufficient number of applications.

Make a move that matters. Join Tandem Diabetes Care, where we’re turning challenges into triumphs every day and where your talents will help shape a healthier, happier tomorrow.

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