Senior Quality Engineer – FDA-Regulated Medical Devices

Tandem Diabetes Care, Inc.; San Diego (CA); Presencial; USD 110.000 - 121.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

ISO experience preferred

Descripción de la vacante

Tandem Diabetes Care, Inc. is seeking a Senior Quality Engineer to drive quality activities across sustaining engineering, production, and quality systems for our medical devices. You will review design changes, verify regulatory compliance, and implement CAPA actions to ensure product safety and reliability.

The role requires strong problem-solving, data analysis, and independent work in an FDA environment, with a focus on improving processes, risk management, and overall quality performance.

Formación

• Bachelor’s degree in a technical field (Mechanical Engineering preferred).
• 5+ years as Quality Engineer in FDA-regulated hardware/medical devices.
• Knowledge of ISO 13485, FDA QMSR, ISO 14971.
• Experience with quality metrics and SPC.
• Ability to work independently and lead audits.

Responsabilidades

• Lead quality activities in sustaining engineering, production, and QA systems.
• Review changes and ensure regulatory documentation.
• Optimize quality, manage risk, and drive improvements.
• Support NCR process and monitor closures.
• Contribute to CO reviews and CAPA investigations.
• Perform Risk Analysis, Process Capability (Cpk), DOE, DV tests.
• Lead cross-functional process improvement teams.
• Analyze customer requirements and tailor company processes.
• Ensure compliance with Privacy/HIPAA and safety policies.

Conocimientos

Quality engineering

FDA-regulated hardware

Statistical analysis

Problem-solving

Independent work

Educación

Bachelor's degree in technical field

Herramientas

Minitab

Excel

MS Office

Descripción del empleo

Tandem Diabetes Care, Inc. is seeking a Senior Quality Engineer to drive quality activities across sustaining engineering, production, and quality systems for our medical devices. You will review design changes, verify regulatory compliance, and implement CAPA actions to ensure product safety and reliability.

The role requires strong problem-solving, data analysis, and independent work in an FDA environment, with a focus on improving processes, risk management, and overall quality performance.