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Sr. Supplier Quality Engineer II – Contract Manufacturing 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 senior team member providing quality guidance and support for supplier management activities such as qualifications, change notifications, audits, evaluations and performance to assure conformance to established standards, specifications and risk reduction. Acts as a leading member of the team to optimize and continuously improve supplier operations to meet department, business unit and company objectives. Provides expertise, guidance and feedback to suppliers to ensure quality materials and components are delivered for use in Tandems insulin pump and insulin cartridge operations.


YOU’RE AWESOME AT:



  • Demonstrated ability to lead, develop, communicate & implement strategies for continuous improvement and development of existing or new suppliers and contract manufacturer.

  • Ability to build relationships and work with suppliers or contract manufacturer to establish and maintain controlled consistent manufacturing processes and methods suitable to the nature of the components or assembly parts they supply.

  • Direct experience with suppliers/contract manufacturer who produce components or assembly parts in a regulatory environment.

  • Proficient knowledge of Quality Engineering policies, principles and best practices including quality standards: ISO 13485, 21CFR Part 820, ISO 14971 and other appropriate industry standards.

  • Competent in QMS Audit and Process Audit practices with ability to readily recognize non-conformances.

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

  • Strong knowledge of and demonstrated experience using statistical techniques: sampling theory, probability, capability, and SPC.

  • Advanced knowledge of and 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 implement solutions.

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

  • Skilled at clearly conveying in-depth knowledge to all levels within, and outside of, the organization.

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

  • Able to objectively evaluate situations and make recommendations for changes in light of overall project demands.

  • 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), MiniTab and other applicable software.

EXTRA AWESOME:



  • Bachelor’s degree in Engineering, preferably Electro-Mechanical Engineering or the equivalent education and applicable work experience.

  • Certified Quality Engineer, Six Sigma Blackbelt, Quality Auditor, or equivalent desired.

  • 8+ years experience working as a Supplier Quality Engineer in a medical device manufacturing or an FDA-regulated industry.

  • Familiarity in the production of PCB, PCBA, electro-mechanical assemblies and plastic molding is highly desirable.

  • Experience in managing 3rd party contract manufacturers is highly desirable.

  • Bi-lingual Spanish is highly desired.

  • Domestic and International travel may be required.

 


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