Senior QA Engineer (Manufacturing)

Posted 3 Days Ago
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Singapore, SGP
In-Office
Senior level
Healthtech
The Role
Lead manufacturing quality engineering initiatives for new products, processes, technologies, and capabilities. Drive risk-based quality planning, validation, manufacturing readiness, control strategies, data-based risk reduction, and compliance across global cross-functional teams. Support digital and automated manufacturing systems, audits, governance, and issue resolution while coaching stakeholders and influencing quality-focused decisions.
Summary Generated by Built In

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. If this sounds like the workplace for you, apply now!

Skills Required

  • 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
  • Experience leading 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 use quality and manufacturing data to identify trends, anticipate risks, influence decisions, and drive preventive actions
  • Strong organizational skills and ability to prioritize competing demands with minimal supervision
  • Effective stakeholder management, communication, and influencing skills, including engagement with senior leaders
  • Ability to collaborate across global, cross-functional teams and influence outcomes without direct authority
  • Background in Quality and/or Regulatory roles within the medical device industry
  • Exposure to MES, digital quality systems, automation, advanced analytics, Computer Software Assurance, Computer System Validation, 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

ResMed Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about ResMed and has not been reviewed or approved by ResMed.

  • Strong & Reliable Incentives — Bonuses are considered a meaningful component of total compensation and are paid regularly. Annual payouts and performance incentives are frequently highlighted alongside base pay.
  • Healthcare Strength — Health coverage is described as comprehensive, including medical, dental, and vision plans that are viewed favorably. Wellbeing resources and flexibility around care reinforce the overall strength of the offering.
  • Equity Value & Accessibility — An employee stock purchase plan is broadly available and regarded as a valuable ownership benefit. Equity elements are positioned as accessible parts of total rewards across many roles.

ResMed Insights

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The Company
HQ: San Diego, CA
5,300 Employees
Year Founded: 1989

What We Do

ResMed provides medical equipment for treating, diagnosing, and managing sleep-disordered breathing and other respiratory disorders.

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