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: https://www.tandemdiabetes.com/careers/life-at-tandem and see what our customers are saying here: #tsliminthewild

WHAT YOU’LL BE DOING:

You’ll act as primary notification and consolidation point for receiving, processing, analyzing and reporting product complaints and corrective and preventative actions. You’ll be responsible for procedural compliance to notified bodies (FDA). Additionally, you’ll collaborate with others in Customer Support, Complaint Evaluation, Clinical Evaluation, Failure Investigation, Risk Management, and other internal groups to support the Complaint Management and CAPA functions.

WHAT YOU NEED FOR THIS POSITION:

• B.S. degree in a scientific or equivalent discipline and applicable complaint management work experience.
• 2 years related experience in the medical device industry.
• Knowledge of FDA requirements and International requirements with regards to complaint handling, and MDR/Global reporting.
• Strong comprehension of the use of medical devices, environment of use and ability to determine if reported issues are reportable based on FDA regulations and International regulations.
• Ability to review extensive complaint information, think critically and determine the best course of action.
• Skilled at documenting events and findings effectively and efficiently.
• Able to review, trend, analyze and report data using databases and/or Excel.
• Strong knowledge of QSR and ISO 13485:2003 requirements.  
• Prior experience with managing medical device complaint files.

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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.

Required Skills Required Experience

• Must exhibit in-depth level of knowledge of DOD manuals, instructions, regulations, guidelines, and ICDs pertaining to national security programs (i.e. DoD 5105.21 V1-3, SECNAVINST 5510.30/36, ICD 704, and ICD 705).
• Must possess superior functional knowledge of task order specific requirements and have experience in developing functional requirements for complex integrated business or security systems.
• Must demonstrate the ability to work independently or under only general direction.
• Pursuant to a government contract, this position requires U.S. Citizenship status.
• A Top Secret with Sensitive Compartmented Information (TS/SCI) access is required.
• Counter Intelligence (CI) Polygraph is required.