Senior Quality Engineer - Sustaining & Compliance

Tandem Diabetes Care Europe B.V.; California; On-site; USD 120,000 - 170,000; Full time

Job summary

Tandem Diabetes Care in the United States is seeking a Senior Quality Engineer to strengthen sterilization and quality systems across hardware development. You will lead sustaining engineering activities, review changes, and ensure regulatory compliance while guiding risk assessment and CAPA programs.

You will collaborate with Manufacturing, Microbiology, Validation, and Regulatory Affairs to maintain ISO 11137, ISO 13485 standards, and FDA QMSR requirements, driving product quality and patient

Qualifications

• Experience leading quality systems in sterilization and cleanroom environments.
• Ability to review/approve product changes with regulatory impact.
• Strong CAPA, risk assessment, and process improvement skills.

Responsibilities

• Serve as Quality lead on sustaining engineering, production, and quality system activities.
• Review and approve changes to ensure regulatory compliance and documented evidence.
• Lead sterilization validation activities and bioburden/sterility data evaluation.
• Coordinate cross-functional teams to ensure ISO 11137, ISO 13485, FDA QMSR compliance.
• Investigate quality-related issues and drive corrective actions (CAPA).
• Support environmental monitoring programs and cleanroom qualification activities.

Skills

Quality systems

Root cause analysis

Sterilization

Environmental monitoring

Risk assessment

CAPA

IQ/OQ/PQ

Tools

Gage R&R

DOE

Job description

Tandem Diabetes Care in the United States is seeking a Senior Quality Engineer to strengthen sterilization and quality systems across hardware development. You will lead sustaining engineering activities, review changes, and ensure regulatory compliance while guiding risk assessment and CAPA programs.

You will collaborate with Manufacturing, Microbiology, Validation, and Regulatory Affairs to maintain ISO 11137, ISO 13485 standards, and FDA QMSR requirements, driving product quality and patient