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Sr Quality Engineer I - Design at Tandem Diabetes Care - ApplyBlast

Sr Quality Engineer I - Design

Tandem Diabetes Care

4 months ago

3.1 on Glassdoor

Irvine, CA

Hybrid

Full Time

Senior

0 applicants

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About this role

The Senior Design Quality Engineer ensures the design, development, and lifecycle management of regulated medical devices meet the highest standards of quality and regulatory compliance. Acting as a key quality leader, this role partners across R&D, Regulatory Affairs, and Manufacturing to drive robust Design Controls and Risk Management practices from concept to post-market support.

Responsibilities

Lead Design Controls in compliance with ISO 13485 and FDA regulations
Drive risk management activities including hazard analysis and FMEA
Oversight of design verification and validation activities across the product lifecycle
Maintain Design History Files and traceability between user needs and outputs
Ensure compliance with Privacy/HIPAA policies and regulatory safety requirements

Skills

Qualifications

Bachelor's degree in Mechanical or Biomedical EngineeringISO 14971 certification knowledgeFDA QSR 21 CFR 820 compliance experience

About Tandem Diabetes Care

tandemdiabetes.com

Headquarters

San Diego, California, United States

Company Size

1001-5000 employees

View Profile

Tandem Diabetes Care designs and manufactures insulin pumps, software and services for diabetes management. Its t:slim X2 pump and Tandem Mobi system run on Control-IQ+ technology, integrate with CGMs, and support remote software updates and data sharing; the company also provides infusion sets, training and 24/7 support, with products marketed globally.