Senior Staff Design Quality Engineer

About the role

The Senior Staff Design Quality Engineer (DQE) is a senior technical individual contributor responsible for ensuring the safety, effectiveness, and regulatory compliance of medical devices throughout the design and development lifecycle. You will act as a recognized subject‑matter expert, guiding quality practices across multiple projects and strategic initiatives.

Key responsibilities

• Implement and maintain robust Quality Management Systems (QMS) for medical device design.
• Lead design control and risk management activities, including FMEA and hazard analysis.
• Ensure compliance with applicable medical device regulations (e.g., FDA 21 CFR Part 820, ISO 13485).
• Develop and execute strategic quality plans aligned with leadership goals.
• Collaborate with cross‑functional internal and external teams to deliver innovative medical solutions.
• Influence and mentor project teams on best‑practice quality methodologies.

Required profile

• Senior‑level technical expertise in design quality engineering for medical devices.
• Proven experience as a subject‑matter expert influencing quality practices across programs.
• Strong ability to lead strategic initiatives and drive continuous improvement.

Required skills

• Quality Management Systems (QMS)
• Design Control
• Risk Management (FMEA, hazard analysis)
• Medical Device Regulations (FDA 21 CFR Part 820, ISO 13485)

What we offer

• Opportunity to work on cutting‑edge medical technologies.
• Collaborative environment with cross‑functional experts.
• Leadership influence on global quality strategy.