Senior Quality Engineer - Medical Devices, Onsite

Tandem Diabetes Care Europe B.V.; California; On-site; USD 120,000 - 180,000; Full time

Job summary

Tandem Diabetes Care is seeking a Senior Quality Engineer to provide quality leadership across sustaining engineering, production, and quality systems for FDA-regulated hardware development. You will review changes, ensure regulatory compliance, and drive risk reduction and quality improvements.

Responsibilities include leading quality activities, supporting audits, and partnering with cross-functional teams to meet compliance and product quality goals.

Qualifications

• Five plus years in quality engineering in FDA-regulated hardware development or medical devices.
• Proficient knowledge of quality standards (ISO 13485, FDA QMSR, ISO 14971).
• Experience with data analysis, datasets querying, and quality metrics.

Responsibilities

• Lead quality activities on sustaining engineering, production, and quality systems.
• Review and approve product/process changes to ensure regulatory compliance.
• Analyze and solve quality problems and drive corrective actions.
• Support audits and risk management activities across hardware development.
• Contribute to Design Reviews, DOEs, V&V testing, and process capability analyses.
• Collaborate cross-functionally to improve product development quality and cost efficiency.

Skills

Quality Engineering

Statistical methods

Gage R&R

DOE

Process improvement

Regulatory compliance

Education

Bachelor's degree in Mechanical Engineering

Tools

Quality measurement equipment

SPC

Job description

Tandem Diabetes Care is seeking a Senior Quality Engineer to provide quality leadership across sustaining engineering, production, and quality systems for FDA-regulated hardware development. You will review changes, ensure regulatory compliance, and drive risk reduction and quality improvements.

Responsibilities include leading quality activities, supporting audits, and partnering with cross-functional teams to meet compliance and product quality goals.