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Quality Engineer, QA Engineering (MQ)

Salary undisclosed

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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!