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Sr. Quality Engineer at Tandem Diabetes Care in San Diego, California

Posted in Science 30+ days ago.

Type: Full-Time





Job Description:

GROW WITH US:


Headquartered in San Diego with customers all over the world, Tandem Diabetes Care is 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. Our offices are centrally located north of Downtown with easy access to the freeway.


DIABETES IS ALL WE DO:


At Tandem, Diabetes is all we do. We are the makers of the only color, touch-screen insulin pump that is capable of remote feature updates and compatibility with continuous glucose monitoring. Read more about our company and check out our latest product features and capabilities here: t:slim X2™ Insulin Pump with Control-IQ™ Technology


In addition to innovative technology, we have a culture that fosters the idea that the happiest people are the most productive people. We treat our fellow employees like friends and family, and the company like our own home. This universal respect allows us the freedom to be ourselves and to be effective at our jobs, knowing at the end of the day that we can trust everyone to do the right thing, for each other and for the company. You can learn more about our culture and life at tandem here:  https://www.tandemdiabetes.com/careers/life-at-tandem and See what our customers are saying here: #tsliminthewild 


A DAY IN THE LIFE:


An experienced team member providing quality guidance and support for product launch, sustaining engineering, production and quality system activities to assure conformance to established specifications and risk reduction. Works independently to optimize and continuously improve internal operations to meet department, business unit and company objectives.  Also provides expertise and guidance to ensure systems are in place across the organization that improves quality of our devices as well as our business operations.


 


YOU’RE AWESOME AT:



  • Demonstrates proficient knowledge of Quality Engineering policies, principles and best practices.

  • Proficient knowledge of quality standards (ISO 13485, 21CFR Part 820, ISO 14971 and other related standard associated to assigned role).

  • Strong knowledge and application of principles outlined in Good Manufacturing Processes (GMP).

  • Understands the use of all test and quality measurement equipment.

  • Strong proficiency of statistical techniques including sampling theory, probability, capability analysis, and SPC.

  • Previous experience generating and analyzing quality metrics.

  • Demonstrated experience using problem solving methodologies: why-why analysis, fault tree analysis, cause and effect diagram etc.

  • Ability to work independently to identify potential quality issues and propose solutions.

  • Basic understanding of mechanical drawings & specifications including geometric dimensioning and tolerances (GD&T).

  • Able to recognize non-conformances from accepted and documented practices.

  • Able to assert own ideas and persuade others through effectively consolidating, evaluating, and presenting relevant information.

  • Skilled at promoting team cooperation and a commitment to team success.

  • Adept at seeing change as an opportunity to improve business performance and campaigning for it when necessary.

  • Ability to effectively use MS Office suite (Word, Excel, Outlook) and MiniTab and other applicable software packages.

 


EXTRA AWESOME:



  • Bachelor’s degree in a technical field, preferably Mechanical Engineering or the equivalent education and applicable work experience.

  • 5+ years experience working as a Quality Engineer in a medical device, manufacturing or FDA-regulated industry.

  • Experience in a GMP or ISO environment strongly preferred.

 


WHAT’S IN IT FOR YOU?


 


At Tandem, our employees are just as important as our customers! Not only do we hire the best, we reward, develop, and retain them too. At Tandem we offer competitive compensation packages, superb medical, dental and vision, a discounted stock purchasing plan, fitness discounts, generous PTO, casual work attire and more! For a full list of benefits please review our perks page at https://www.tandemdiabetes.com/careers/benefits.


 


REFERRALS:


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


 


If you are applying for this job and live in California, please read Tandem’s CCPA Notice:


https://www.tandemdiabetes.com/careers/california-consumer-privacy-act-notice-for-job-applicants