Senior QA Engineer

The primary focus of this Quality Assurance (QA) role is to support manufacturing operations, ensuring that robust management systems are in place to enable compliance with regulatory frameworks and deliver safe, effective products to our customers. This position plays a critical role in driving quality within the factory environment by partnering closely with manufacturing teams, supporting the introduction of new products into production, and ensuring that all manufacturing processes meet internal and external quality requirements.

Key deliverables include building strong relationships with medical device regulatory bodies in every country, ensuring timely registration to meet business needs. The role also covers auditing activities to confirm regulatory compliance, driving quality best practices, process improvements, and development of supplier quality systems.

Key Responsibilities

• Collaborate with Factory Focus Teams to meet Quality, Delivery, and Cost (QDC) targets.

• Lead and support the New Product Introduction (NPI) process into manufacturing, working with cross-functional teams (XFTs) and Quality/Regulatory counterparts.

• Drive continuous improvement in manufacturing quality systems, ensuring consistent practices across ResMed's global manufacturing sites.

• Conduct reviews across manufacturing lines and support QA teams to identify process gaps, risks, and improvement opportunities.

• Ensure manufacturing activities comply with ResMed's Quality Management System (QMS) and all applicable international regulatory standards (e.g., FDA, ISO

• Act as a QA representative for key manufacturing-related projects such as:

  • Site expansions or relocations

  • Integration of new production technologies

  • Supplier or contract manufacturer onboarding

• Lead and support internal, supplier, and regulatory audits related to manufacturing processes.

• Prepare and maintain Quality Agreements, Quality Plans, and Risk Assessments specific to manufacturing operations.

• Support validation activities including process validations, equipment qualifications, and product inspections.

• Coach, mentor, and provide technical quality leadership within the QA Manufacturing team.

• Collaborate with other QA functions (Design QA, Supplier QA, Customer QA) to ensure full product lifecycle quality coverage.

Qualifications & Experience

Required:

• Bachelor's degree in Engineering or Science.

• Minimum 5 years' experience in a regulated, high-volume manufacturing environment (ideally medical devices, pharmaceuticals, or automotive).

• Strong hands-on experience in:

  • Manufacturing QA and process validation

  • Non-conformance investigations, CAPA, change control

  • Regulatory compliance (FDA, ISO 13485, GMP)

• Demonstrated ability to lead projects, work independently, and meet deadlines.

• Strong stakeholder engagement and communication skills.

• Experience working with global teams and across multiple manufacturing sites.

Preferred:

• Experience in medical device manufacturing and regulatory submissions.

• Familiarity with lean manufacturing, Six Sigma, or root cause analysis tools.

• Previous involvement in supplier quality or auditing.

Why ResMed?

Joining us means being part of a global leader in medical technology with a mission to change lives with every breath. You'll work in a dynamic manufacturing environment where innovation, quality, and compliance go hand in hand.

We offer a supportive and inclusive culture that fosters professional growth and celebrates diversity.

Ready to bring your manufacturing QA expertise to a company that's improving millions of lives worldwide?

Apply now and help us build a healthier future.

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