Senior QA Engineer (Manufacturing)

About the role

Resmed is looking for a Senior QA Engineer (Manufacturing) based in Tuas, Singapore. The role provides technical leadership in manufacturing quality, working across Manufacturing Engineering, Operations, Product Development, Digital and Quality teams. You will help embed quality into processes, technologies and systems, lead complex Quality Engineering initiatives and drive manufacturing readiness for strategic programs.

Key responsibilities

• Lead Quality Engineering activities for new products, processes, technologies and manufacturing capabilities, embedding quality requirements throughout development and launch.
• Drive risk-based quality planning, manufacturing readiness assessments, validation activities and control strategy development.
• Deploy and enhance Manufacturing QA standards, playbooks, tools and methodologies across teams and sites.
• Analyze manufacturing and quality data to identify systemic risks, reduce issue recurrence and improve Right First Time performance.
• Support quality activities for automation, MES, digital quality systems, software-enabled manufacturing and digital assurance initiatives.
• Develop quality strategies, readiness plans and preventive controls, and coach and mentor others.
• Partner with Manufacturing Engineering, Operations, Product Development, Digital/GTS and Quality teams, and escalate quality risks in governance forums.
• Support internal, external and supplier audits in line with the Resmed Quality Management System and regulatory requirements.

Required profile

• Bachelor's degree in Engineering or Science.
• Minimum 5 years of experience in a regulated, high-volume manufacturing environment.
• Proven ability to lead complex Quality Engineering initiatives.
• Preferred: background in Quality and/or Regulatory roles in the medical device industry.

Required skills

• Quality systems, manufacturing quality, risk management, requirements management, process validation and process capability improvement.
• Risk-based assurance for digital and software-enabled manufacturing technologies.
• Data analysis to identify trends and drive preventive actions.
• Stakeholder management, communication and collaboration across global, cross-functional teams.
• Preferred: exposure to MES, digital quality systems, automation, advanced analytics, CSA, CSV, QbD or technology-enabled inspection, and use of AI tools.