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Sr. Quality Engineer I - Manufacturing / Sterilization

Tandem · California - Barnes · On-site

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About Tandem

AI-native office leasing broker. Backed by Y Combinator and a16z.

About the role

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. · Serves as a Quality lead on sustaining engineering, production, and quality system activities. Found on 1752vc Careers, the job board for startup and VC roles.

What they're looking for

  • Bachelor’s degree in a technical field, preferably Mechanical Engineering or the equivalent education and applicable work experience
  • 5 plus years’ experience working as a Quality Engineer in an FDA-regulated hardware development environment, medical device development, or an FDA-regulated industry
  • Demonstrates proficient knowledge of Quality Engineering policies, principles and best practices
  • Proficient knowledge of quality standards (ISO 13485, FDA QMSR, ISO 14971)
  • Proficient knowledge and experience with sterilization, bacterial endotoxin testing, and cleanroom standards (ISO 11137-1, ISO 11137-2, ISO 11737-1, ISO 11737-2, ISO 11737-3, AAMI ST72, ISO 14644-1)
  • Understands the use of all test and quality measurement equipment
More about this role

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.

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

An experienced senior team member in a sustaining, manufacturing environment with ample knowledge and experience in sterilization, bacterial endotoxin testing, and cleanroom activities providing quality guidance and support for product launch, sustaining...

Read the full posting on Tandem's site ↗

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