Senior QA Engineer (Manufacturing)

ResMed (Malaysia) Sdn Bhd (MY); Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

ResMed in Singapore is seeking a Senior QA Engineer (Manufacturing) based in Tuas to provide technical leadership in manufacturing quality, ensuring products are developed and produced to the highest standards of quality, compliance, and operational performance.

You will collaborate with Manufacturing Engineering, Operations, Product Development, Digital and Quality teams to embed quality into processes, technologies and systems, and to lead strategic quality initiatives across ResMed’s

Qualifications

• Bachelor's degree in Engineering or Science.
• Minimum 5 years of experience in a regulated, high-volume manufacturing environment.
• Knowledge of Quality Systems, Manufacturing Quality, risk management, requirements management, process validation, and process capability improvement.
• Proven ability to lead complex Quality Engineering initiatives across products, processes, technologies, or manufacturing sites.
• Understanding of risk-based assurance principles for digital and software-enabled manufacturing technologies.
• Ability to leverage quality and manufacturing data to identify trends, anticipate risks, influence decisions, and drive preventive actions.
• Excellent organizational skills with the ability to prioritize competing demands and deliver results with minimal supervision.
• Effective stakeholder management, communication, and influencing capability, including engagement with senior leaders.
• Ability to collaborate across global, cross-functional teams and influence outcomes without direct authority.

Responsibilities

• Lead complex Quality Engineering activities for new products, processes and manufacturing capability introductions, ensuring quality requirements are embedded throughout development and launch.
• Drive risk-based quality planning, manufacturing readiness assessments, validation activities, and control strategy development for strategic manufacturing initiatives.
• Deploy and enhance Manufacturing QA standards, playbooks, tools, and methodologies to improve consistency and capability across teams and sites.
• Analyze manufacturing and quality data to identify systemic risks, reduce recurrence of issues, improve Right First Time performance, and strengthen future manufacturing designs.
• Support quality activities for automation, MES, digital quality systems, software-enabled manufacturing processes, and digital assurance initiatives.
• Develop and implement manufacturing quality strategies, readiness plans, and preventive control mechanisms that support sustainable compliance and operational performance.
• Provide technical leadership through coaching, mentoring, structured problem-solving, and risk-based decision-making.
• Partner with Manufacturing Engineering, Operations, Product Development, Digital/GTS, and Quality teams to influence process, technology, and system design decisions.
• Participate in governance forums, escalating quality risks where appropriate and driving effective resolution of compliance and operational issues.
• Support internal, external, and supplier audits while ensuring compliance with the Resmed Quality Management System and applicable regulatory requirements.

Skills

Quality Systems

Manufacturing Quality

Risk management

Requirements management

Process validation

Process capability

Leadership

Stakeholder management

Education

Bachelor's degree in Engineering or Science

Tools

MES

Digital quality systems

Automation

Advanced analytics

Computer Software Assurance (CSA)

CSV

Quality by Design

Inspection solutions

Job description

As a Senior QA Engineer (Manufacturing) based in Tuas, you will provide technical leadership in manufacturing quality, helping to ensure products are developed and produced with the highest standards of quality, compliance, and operational performance. Working across Manufacturing Engineering, Operations, Product Development, Digital, and Quality teams, you will influence how quality is designed into processes, technologies, systems, and future manufacturing capabilities. This role offers the opportunity to lead complex Quality Engineering initiatives, drive manufacturing readiness for strategic programs, and shape quality practices that support both current operations and future-state transformation across Resmed.

Responsibilities

• Lead complex Quality Engineering activities for new products, processes, technologies, and manufacturing capability introductions, ensuring quality requirements are embedded throughout development and launch.
• Drive risk-based quality planning, manufacturing readiness assessments, validation activities, and control strategy development for strategic manufacturing initiatives.
• Deploy and enhance Manufacturing QA standards, playbooks, tools, and methodologies to improve consistency and capability across teams and sites.
• Analyze manufacturing and quality data to identify systemic risks, reduce recurrence of issues, improve Right First Time performance, and strengthen future manufacturing designs.
• Support quality activities for automation, MES, digital quality systems, software-enabled manufacturing processes, and digital assurance initiatives.
• Develop and implement manufacturing quality strategies, readiness plans, and preventive control mechanisms that support sustainable compliance and operational performance.
• Provide technical leadership through coaching, mentoring, structured problem-solving, and risk-based decision-making.
• Partner with Manufacturing Engineering, Operations, Product Development, Digital/GTS, and Quality teams to influence process, technology, and system design decisions.
• Participate in governance forums, escalating quality risks where appropriate and driving effective resolution of compliance and operational issues.
• Support internal, external, and supplier audits while ensuring compliance with the Resmed Quality Management System and applicable regulatory requirements.

Qualifications:

• Bachelor's degree in Engineering or Science.
• Minimum 5 years of experience within a regulated, high-volume manufacturing environment.
• Knowledge of Quality Systems, Manufacturing Quality, risk management, requirements management, process validation, and process capability improvement.
• Proven ability to lead complex Quality Engineering initiatives across products, processes, technologies, or manufacturing sites.
• Understanding of risk-based assurance principles for digital and software-enabled manufacturing technologies.
• Ability to leverage quality and manufacturing data to identify trends, anticipate risks, influence decisions, and drive preventive actions.
• Excellent organizational skills with the ability to prioritize competing demands and deliver results with minimal supervision.
• Effective stakeholder management, communication, and influencing capability, including engagement with senior leaders.
• Ability to collaborate across global, cross-functional teams and influence outcomes without direct authority.

Preferred Background

• Background in Quality and/or Regulatory roles within the medical device industry.
• Exposure to MES, digital quality systems, automation, advanced analytics, Computer Software Assurance (CSA), CSV, Quality by Design, or technology-enabled inspection solutions.
• Demonstrated application of AI tools or data-driven technologies to improve efficiency, quality insights, or decision-making.

What Sets You Apart

• Strategic Thinking: Anticipates risks and opportunities while balancing immediate operational needs with long-term quality objectives.
• Ownership: Takes accountability for outcomes and drives priorities through to completion with a sense of urgency.
• Influence: Builds alignment across diverse stakeholders and gains support for quality-focused decisions through credibility and trust.
• Continuous Improvement: Challenges the status quo and seeks better ways to strengthen processes, systems, and team capability.
• Collaboration: Creates productive partnerships across functions, fostering shared accountability for business and quality outcomes.
• Resilience: Navigates complexity and change with confidence while maintaining focus on delivering results.

Why Join Resmed

At Resmed, your work helps improve lives through innovative healthcare solutions that make a meaningful difference for patients around the world. As a Senior QA Engineer, you'll play a critical role in shaping manufacturing quality strategies, advancing digital and automated manufacturing capabilities, and influencing future-state quality practices. You'll work with talented global teams, contribute to transformational initiatives, and have the opportunity to leave a lasting impact on both manufacturing excellence and patient outcomes.

Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates.