Senior QA Engineer — Quality & Compliance Leader (Global)

Regulatory Jobs; San Diego (CA); Vor Ort; USD 87.000 - 145.000; Vollzeit

Benefits dieser Stelle

Comprehensive benefits

Global growth opportunities

Career development programs

Industry-leading company

Zusammenfassung

Dexcom Corporation is seeking a seasoned Quality Engineer to lead complex quality investigations and drive compliance across the product lifecycle. You will provide technical leadership in quality engineering, continue improvement, validation strategies, and software V&V expertise.

You will partner with R&D, Regulatory Affairs, Manufacturing and global teams to ensure robust quality solutions. Join a fast-paced, cross‑functional team focused on CGM technology and patient outcomes.

Qualifikationen

• Bachelor’s degree in a technical discipline with 5–8 years related experience
• Master’s degree with 2–5 years, or PhD with 0–2 years experience

Aufgaben

• Lead complex quality investigations and root cause analysis with CAPAs and MRBs
• Provide technical leadership in quality engineering and continuous improvement
• Drive Quality Management System excellence through procedures and validation frameworks
• Own validation/qualification strategies for equipment, processes, test methods and software V&V
• Serve as quality engineering lead on cross‑functional projects with R&D, Regulatory, Manufacturing
• Guide design transfer and commercialization to scale from development to high-volume manufacturing
• Mitigate risk by influencing design decisions and implementing robust controls
• Identify and close compliance gaps across sites and functions
• Communicate technical/compliance topics effectively to stakeholders
• Represent Quality during internal audits and regulatory inspections

Kenntnisse

Quality engineering

Risk management

Root cause analysis

Six Sigma

Data analysis

Ausbildung

Bachelor’s degree in technical discipline

Master’s degree

Tools

JMP

Excel

Jobbeschreibung

Dexcom Corporation is seeking a seasoned Quality Engineer to lead complex quality investigations and drive compliance across the product lifecycle. You will provide technical leadership in quality engineering, continue improvement, validation strategies, and software V&V expertise.

You will partner with R&D, Regulatory Affairs, Manufacturing and global teams to ensure robust quality solutions. Join a fast-paced, cross‑functional team focused on CGM technology and patient outcomes.