Senior Quality Engineer - Medical Devices (On-Site)

Tandem Diabetes Care, Inc.; United States; Vor Ort; USD 110.000 - 121.000; Vollzeit

Benefits dieser Stelle

ISO environment experience

Zusammenfassung

Tandem Diabetes Care, Inc. is seeking a Senior Quality Engineer to lead sustaining engineering, oversee quality system activities, and ensure regulatory conformance across hardware development and production.

This role emphasizes risk management, data-driven decisions, and cross-functional collaboration. Ideal candidates will have 5+ years in FDA-regulated hardware or medical devices, strong knowledge of ISO 13485 and related standards, and proficiency with quality metrics and statistical

Qualifikationen

• Bachelor’s degree in a technical field; Mechanical Engineering preferred.
• 5+ years of quality engineering in FDA-regulated hardware or medical devices.
• Solid knowledge of quality systems, ISO 13485, FDA QMSR, and ISO 14971.
• Proficient with statistics, sampling theory, capability analysis (SPC), and GD&T.
• Experience using problem-solving methodologies and data analysis tools.

Aufgaben

• Lead sustaining engineering, production, and quality system activities as Quality lead.
• Review and approve product/process changes to ensure regulatory conformance.
• Drive risk management, CAPA, NCRs, and quality system improvements.
• Analyze quality metrics, perform root cause analyses, and drive corrective actions.
• Support IQ/OQ/PQ development for processes and equipment.

Kenntnisse

Quality Engineering

FDA Regulations

Statistical Methods

GD&T

MS Office

MiniTab

Ausbildung

Bachelor's degree in engineering

Tools

MiniTab

MS Office

Jobbeschreibung

Tandem Diabetes Care, Inc. is seeking a Senior Quality Engineer to lead sustaining engineering, oversee quality system activities, and ensure regulatory conformance across hardware development and production.

This role emphasizes risk management, data-driven decisions, and cross-functional collaboration. Ideal candidates will have 5+ years in FDA-regulated hardware or medical devices, strong knowledge of ISO 13485 and related standards, and proficiency with quality metrics and statistical