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
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.
- 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.
- 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.
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