Senior QA Engineer, Quality & Risk Leadership

Dexcom, Inc.; San Diego (CA); Vor Ort; USD 111.000 - 185.000; Vollzeit

Zusammenfassung

Dexcom, Inc. is seeking a senior Quality Engineer with a strong background in risk management and process validation to lead high-visibility quality investigations across multiple sites.

You will shape corrective actions, perform root cause analyses, and drive improvements in QMS and product safety for CGM technologies. The role requires technical leadership, excellent communication to senior leadership, and the ability to navigate ambiguity while supporting design transfer and scale-up to

Qualifikationen

• Bachelor’s degree in a technical discipline with quality engineering experience in regulated manufacturing.
• Experience applying risk-based validation and procedures for IQ/OQ/PQ/PV and TMV.
• Proven ability to distill complex technical information and present to leadership.

Aufgaben

• Lead complex, high-risk quality investigations including CAPAs and HHEs.
• Provide technical leadership in risk management, process validation, and V&V.
• Drive QMS excellence, identify systemic weaknesses, and implement improvements.
• Represent Quality during audits and regulatory inspections with clear written and oral communication.

Kenntnisse

Risk management

Root cause analysis

Six Sigma

Statistical analysis

FMEAs

Quality leadership

Documentation

Cross-functional collaboration

Ausbildung

Chemical Engineering or similar degree

Tools

JMP

Excel

Jobbeschreibung

Dexcom, Inc. is seeking a senior Quality Engineer with a strong background in risk management and process validation to lead high-visibility quality investigations across multiple sites.

You will shape corrective actions, perform root cause analyses, and drive improvements in QMS and product safety for CGM technologies. The role requires technical leadership, excellent communication to senior leadership, and the ability to navigate ambiguity while supporting design transfer and scale-up to