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Quality Engineer, QA Engineering (MQ)

Salary undisclosed

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ResMed is a global leader in sleep technology, dedicated to improving millions of lives through innovative solutions for sleep apnea, COPD, and other chronic diseases. Join our team and be part of a company committed to creating devices that make a difference in the world.

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.