Design Quality Lead

About the role

HRnetOne is hiring a Design Quality Lead in Thailand to lead design quality assurance across the entire Product Development Lifecycle (PDLC) and guide R&D teams on design controls. The role also oversees the design-related Quality Management System and ensures compliance with international regulatory requirements.

Key responsibilities

• Lead design quality assurance activities throughout the Product Development Lifecycle (PDLC).
• Guide R&D teams on design controls, including design inputs, outputs, verification and validation.
• Oversee and manage the Quality Management System (QMS) processes specific to design and development.
• Facilitate risk management activities, including FMEA and hazard analysis.
• Manage and lead CAPA and NCR processes so quality issues are resolved promptly.
• Ensure technical documentation and Design History Files (DHF) comply with regulations such as ISO 13485 and FDA 21 CFR 820.

Required profile

• Minimum 5 years of experience in Design Quality or a similar R&D quality role in the medical device industry.
• Bachelor's degree in Engineering, Life Sciences or a related technical field.
• Excellent command of English, written and spoken, for work with international stakeholders.

Required skills

• Strong working knowledge of QMS, CAPA and NCR procedures.
• Knowledge of FMEA and hazard analysis.