At Spacelabs Healthcare, we’re committed to transforming healthcare through continuous innovation. Our scalable solutions deliver critical patient data across local and remote systems, empowering better decisions, improving efficiency, and enhancing patient safety. The Role We’re seeking a Senior Quality Assurance Engineer to lead and support Quality Management System (QMS) performance across design, manufacturing, service, and compliance functions. This role is pivotal in ensuring our medical devices are safe, effective, and compliant with global standards. Key Responsibilities Design Control & Product Development - Mentor design teams on Design Controls, Risk Management, and Electrical Safety. - Review Engineering Change Orders for sound engineering practices and compliance. - Support technical documentation including Essential Requirements Checklists and Risk Management Files. - Collaborate with engineering on regulatory submissions and design planning. Manufacturing & Process Improvement - Oversee manufacturing processes, work instructions, and inspection protocols. - Approve Device History Records to ensure compliance with Device Master Record requirements. - Conduct 7S-based floor walkthroughs to drive operational improvements. Post-Market Surveillance ...