Quality Engineer, QA Engineering (MQ)

Job Description Summary:

To support/improve production quality and GMP compliance to meet Quality, Delivery and Cost through the development and application of quality systems in production.

Let’s talk about Responsibilities

• Support the Factory Focus teams to achieve the deliverables for current KPI of Quality, Delivery and Cost.

• Assist to improve quality systems to support manufacturing including reviews across all areas of manufacturing and QA production support team to ensure a level of consistency and standardization in ResMed QMS across various manufacturing business units and sites.

• Assist in risk of non-compliance and related business risks are mitigated.

• Support/remote support technical leadership in Quality Engineering across global team.

• Build positive working relationships with internal and external customers to ensure QA purpose and vision is recognized as integral to business success and growth.

• Foster quality culture through involvement in ongoing education, consultation in the Quality/Regulatory requirements

• Ensure compliance to ResMed QMS and overall compliance to applicable regulatory standards.

Let’s talk about Qualifications:

• Tertiary Qualification in Engineering or Science

• Excellent English written and verbal communication skills, with the ability to communicate technical information clearly and effectively.
• Strong attention to detail and accuracy, with the ability to review and interpret technical documentation.
• Ability to work independently and collaboratively in a fast-paced environment with changing priorities.

Preferred

• Knowledge of quality management systems, regulatory requirements (e.g., ISO 13485, FDA regulations), and medical device standards (e.g., ISO 14971, IEC 60601).

• Previous experience in a quality assurance role in the medical device or pharmaceutical industry.

• Strong analytical and problem-solving skills, with the ability to identify issues, analyze data, and implement effective solutions.

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!