Sr. Quality Engineer - Manufacturing

Tandem Diabetes Care · Barnes, CA

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Role summary

Senior Quality Engineer supporting manufacturing operations for insulin pump devices at a diabetes technology company. The role involves sterilization validation, cleanroom environmental control, process improvements, and quality system oversight to ensure regulatory compliance and product safety.

Where this listing comes from

This listing was compiled by RoleLantern from the employer's publicly available posting on Workday, captured and rephrased by RoleLantern using automated (AI) tools on 2026-10-03 (originally posted 2026-10-03). It was not submitted or confirmed by the employer through RoleLantern. Details may be inaccurate, incomplete, outdated, or no longer available; please confirm with the employer's official posting before applying.

What they're looking for

Bachelor's degree in technical field, preferably Mechanical Engineering or equivalent
5+ years quality engineering experience in manufacturing environments
Expertise in sterilization processes, bacterial endotoxin testing, and cleanroom operations
Knowledge of ISO 11137, ISO 13485, ISO 14644, and FDA quality system regulations
Experience with validation protocols, non-conformance investigation, and root cause analysis
Proficiency in statistical analysis, process capability, design of experiments, and risk assessment

What you'll be doing

Lead sterilization validation activities including dose establishment, audits, and compliance monitoring
Oversee cleanroom environmental monitoring programs and investigate excursions or control deviations
Review and approve product, process, and design changes for regulatory conformance
Conduct quality investigations, root cause analyses, and support corrective/preventive actions
Collaborate with cross-functional teams on process improvements and quality system enhancements

Privacy & handoff

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About this role

Sr. Quality Engineer - Manufacturing is a senior quality role at Tandem Diabetes Care, based in California - Barnes. It was posted today. RoleLantern last confirmed the employer's listing is still open today.

Typical pay for this kind of role: $94k–$145k

Tandem Diabetes Care hasn't published pay for this listing. Across the U.S., bioengineers & biomedical engineers typically earn $94k to $145k, with a median of $116k (adjusted for seniority). Ask about the range early — several states require employers to share it.

Source: U.S. BLS OEWS (May 2023, national). See the full salary guide

• Tandem Diabetes Care has 36 other open roles on RoleLantern, 4 of them in quality.
• There are 229 open quality roles in California right now.

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