Senior Design Quality Engineer

About the role

The Senior Design Quality Engineer will provide technical support and service for all aspects of quality engineering, ensuring compliance with safety standards and global regulatory requirements. This role combines product development, risk management, and continuous improvement within a global healthcare organization.

Key responsibilities

• Apply innovative techniques to develop or improve products and processes, leading several moderate projects across multiple products.
• Plan, schedule, and lead cross‑functional teams through detailed phases of quality work, managing continuous improvement projects to achieve quality, reliability, and complaint reduction.
• Lead audit‑ready status efforts, support FDA, ISO, and Baxter quality requirements, and take a lead role in NCR/CAPA activities.
• Support risk management, post‑market surveillance, and provide product quality support for new product development, design transfer, and sustaining engineering.

Required profile

• Bachelor’s degree in engineering with at least three years of experience in quality, manufacturing, or engineering in the medical device or biologics/therapeutics field.
• Product development experience with medical devices, including work with Design History Files (DHF) and Risk Management Files (RMF).
• Demonstrated leadership in sustaining product support, complaint investigations, trigger evaluations, and design change controls.

Required skills

• Solid understanding of FDA regulations (21 CFR Part 820), Good Laboratory Practices, Good Manufacturing Practices.
• Knowledge of ISO 13485, ISO 14971, IEC 60601, IEC 62304, and EU MDD/MDR requirements.
• Experience with design history file (DHF) management and risk management file (RMF) processes.
• Project management skills for coordinating technical and project overviews.