Supervisor, Quality Assurance (Operations)

Tandem Diabetes Care San Diego , CA 92140

Posted 4 weeks ago

What you'll be doing:

You'll lead and coordinate the activities of employees engaged in the following areas: in-process inspections, final QA inspection, sterilization approval and product acceptance for commercial release. Conducts routine and non-routine documentation review of production quality records according to Tandems Quality System procedure. Other responsibilities include drafting procedures and assisting with validating or troubleshooting testing methods as well as creating, reviewing and enhancing procedures to ensure compliance. You'll also monitor and measure effectiveness of overall quality focusing on training and development, engineering change review, and quality systems audits.

Shift Schedule: Monday - Thursday (4X10), 2:30 PM - 1:30 PM

  • Performs final product acceptance of Tandems products before commercial release.

  • Identifies non-conforming materials that fail to meet product acceptance requirement and initiates NCRs.

  • Monitors manufacturing, development, and quality processes to ensure conformance and compliance with all FDA and applicable international regulations.

  • Provides guidance to and ensures compliance in GMP training practices and documentation.

Leading the Team

  • Supervises the Quality Assurance team, mentors and motivates the team members, ensuring individual and group efficiency.

  • Acts as a communication hub for the team, disseminating and escalating pertinent and timely information.

  • Keeps the department management abreast of activities and issues of the quality inspection group and informs appropriate groups of trends.

  • Schedules routine QA functions, as well as special production or engineering needs.

  • Works with production lead or supervisor to ensure the schedule supports the QA workload.

  • Assists in performing hands-on QA functions as needed.

  • Uses information databases and other tools to measure cycle time, backlog, aging awaiting finished products to assure inventory is maintained to the desired level.

  • Participates in the selection, development, and evaluation of team members to ensure the efficient operation of the function.

  • Measures, tracks, and assesses staff productivity and efficiency; to recommend action to correct the negative trend.

Continuous Improvement

  • Reviews and implements continuous improvement projects.

  • Trains team members and works with Manufacturing and Quality Engineering to implement lean processes.

  • Identifies, recommends and implements changes that improve efficiency.

Quality System/Compliance:

  • Supports the establishment, implementation, and maintenance of quality system as they apply to:

  • Final QA acceptance to ensure they are in compliance with Quality System Regulations, (21CFR Part 820) and ISO 13485.

  • And other applicable standard that applies to final QA acceptance.

  • Maintains and closely follows department standard operating procedures and work instructions.

  • Keeps the workplace clean and orderly, enforcing Good Manufacturing Practices.

  • Responsible to confirm quarantine and labeling of any non-conforming material, product or equipment.

  • Monitors manufacturing, development, and quality processes to ensure conformance and compliance with all FDA and applicable international regulations.

  • Provides guidance to and ensures compliance in GMP training practices and documentation.

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.

We've have been named one of the fastest growing insulin pump companies in the U.S! Why? Designed, assembled and supported from our San Diego, CA headquarters, Tandem has created the simple-to-use t:slim X2 Insulin Pump, which is the smallest pump available, the only color touch-screen insulin pump capable of remote feature updates, and the first CGM-enabled pump approved to let users make treatment decisions without pricking their finger.

Read more about our company & culture here: and see what our customers are saying here: #tsliminthewild

What you need for this position:

  • BA/BS degree in a scientific discipline or combination of High School Diploma and equivalent applicable work expereinence.

  • 8 years' related QA experience or 10 years' relevant manufacturing experience in an FDA regulated industry preferred.

  • Experience in medical device or in-vitro diagnostic organizations with instrumentation experience is preferred.

  • Familiar with the QSR and ISO13485:2003 requirements.

  • Experience implementing and working within quality management systems.

  • Working knowledge of QSR, ISO, FDA and GMP concepts and guidelines.

  • Very strong interpersonal skills and ability to work with others in a positive and collaborative manner.

  • Ability to effectively exchange or present information in both written and verbal communications.

  • Ability to assertively identify and resolve issues that hinder team performance.

  • Strong computer skills, including Microsoft Word and Excel.

What's in it for you?

We've got you covered. We offer a robust benefits package to support your health and your family. From medical, dental, and vision, to flexible spending accounts for both health and dependent care Tandem's got you covered!

Stay well with us. Enjoy the outdoors during your workday by biking, running, or walking on one of our nearby trails. Or check out our offsite gym, which boasts luxurious amenities including specialty fitness classes and state-of-the-art equipment.

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.

Live your life. Relax with 20 days of paid time off and celebrate 10 paid holidays in your first year. Save for your future with a company-provided 401(k) plan. Look forward to saving money on tickets to the San Diego Zoo, movies, restaurants, and so much more with our exclusive employee discount program.

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 walk.

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Supervisor, Quality Assurance (Operations)

Tandem Diabetes Care