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Drive excellence in product and process quality by leading quality initiatives across medical manufacturing operations.
About The Role
This is a key opportunity to play a significant role in ensuring compliance and enhancing customer satisfaction in a dynamic environment.
- Collaborate with operational leaders to improve and maintain product quality.
- Supervise Quality Control Officers (QCOs) and support the escalation of production issues.
- Partner with the Technical team to validate product compliance and implement effective Corrective Action Plans (CAPAs).
- Conduct internal audits and host third-party certification audits.
- Manage process analysis and ensure measurable outcomes.
- Identify training needs and implement quality-related programs.
- Support product rejects, returns, and complaints with compliant corrective actions.
- Ensure timely resolution of audit findings.
- Assist with trials and change management processes.
Key Requirements
We're seeking an individual with:
- Solid experience in quality management within a manufacturing environment.
- A strong understanding of Quality Management Systems (QMS), including ISO 9001 standards.
- Experience conducting internal audits and managing CAPAs.
- Excellent communication and problem-solving skills.
- Proficiency in MS Office (Word, Excel, Outlook).
- Tertiary qualification in a related discipline will be highly regarded.
- Experience in a TGA-approved or medical device manufacturing environment is preferred but not essential.
