Senior Quality Engineer, Medical Devices (On-Site)

Tandem Diabetes Care, Inc.; San Diego (CA); On-site; USD 110,000 - 121,000; Full time

Job summary

Tandem Diabetes Care, Inc. in San Diego, CA seeks an experienced Quality Engineer for a manufacturing role focusing on sterilization, endotoxin testing, and cleanroom activities.

You will lead quality systems, drive risk reduction, and ensure conformance to specifications for patient safety and product quality. Requirements include a technical Bachelor's, 5+ years in FDA-regulated hardware/medical devices, ISO 13485 proficiency, and strong statistics.

Qualifications

• Bachelor's degree in a technical field and 5+ years in FDA-regulated hardware/medical device quality.
• Proficient knowledge of ISO 13485, FDA QMSR and related quality principles.
• Experience with sterilization processes, endotoxin testing, and cleanroom standards.
• Strong analytical skills, statistics, and data-driven problem solving.
• Ability to review changes, manage risk, and ensure regulatory compliance.
• Proficiency with GD&T, measurement equipment, and MS Office tools.

Responsibilities

• Lead quality engineering activities in sustaining and manufacturing environments.
• Review and approve changes to ensure verification, validation, and documentation.
• Drive risk management, CAPA, and continuous improvement initiatives.
• Monitor environmental monitoring and sterilization validation programs.
• Collaborate cross-functionally to ensure patient safety and product quality.

Skills

Quality Engineering

ISO 13485 knowledge

FDA QMSR knowledge

Sterilization knowledge

Statistical techniques

Problem solving

GD&T knowledge

MS Office / MiniTab

Education

Bachelor's degree in Mechanical Engineering or related field

Tools

MiniTab

Quality management software (document control systems)

Job description

Tandem Diabetes Care, Inc. in San Diego, CA seeks an experienced Quality Engineer for a manufacturing role focusing on sterilization, endotoxin testing, and cleanroom activities.

You will lead quality systems, drive risk reduction, and ensure conformance to specifications for patient safety and product quality. Requirements include a technical Bachelor's, 5+ years in FDA-regulated hardware/medical devices, ISO 13485 proficiency, and strong statistics.