Senior Quality Engineer I – Medical Devices, Onsite

Tandem Diabetes Care, Inc.

California

On-site

USD 110,000 - 121,000

Full time

2 days ago

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Benefits offered by this job

ISO environment experience

Job summary

Tandem Diabetes Care, Inc. is seeking a Senior Quality Engineer to join our on-site manufacturing and development teams in California.

You will lead quality activities across sustaining engineering, production, and quality systems, ensuring compliance with regulatory requirements and driving improvements. With 5+ years in FDA-regulated hardware or medical device quality, you will review changes, analyze data, and mentor cross-functional teams to deliver robust, compliant products while advancing

Qualifications

Bachelor’s degree in a technical field required.
5+ years of Quality Engineer experience in FDA-regulated hardware/medical device development.
Proficient knowledge of ISO 13485, FDA QMSR, ISO 14971.
Experience with quality metrics and SPC.
Ability to lead cross-functional teams and audits.

Responsibilities

Lead quality on sustaining engineering, production, and quality system activities.
Review and approve product and process changes to ensure regulatory compliance.
Analyze and solve quality-related problems with products and processes.
Support risk analysis, design reviews, and reliability testing.
Lead audits and drive continuous improvement in quality systems.