
Chief Quality Assurance Professional
7 days ago
Job Overview:
We are seeking an experienced Quality Manager to join our team. In this role, you will be responsible for championing quality within the organization and ensuring overall compliance to standard operating procedures in line with the Quality Management System (QMS).
- Key Responsibilities:
- Maintain and improve our QMS in accordance with ISO 13485 and ISO 9001 standards.
- Develop audit programs and plans, perform internal audits, and coordinate external audits.
- Identify opportunities for improvement in company processes and systems, and work with subject matter experts to drive implementation.
- Manage CAPA related activities, including risk management in accordance with best practices.
- Manage quality for the development of medical devices according to regulation such as CE MDR, FDA, and TGA, and standards including ISO 13485, IEC 60601, and IEC 62304.
- Manage the calibration of test and measurement equipment.
- Select and evaluate suppliers, monitor quality agreements, and manage actions arising from goods inspection.
- Develop and conduct induction and training on QMS processes and policies.
Requirements:
- A relevant qualification from a reputable education organization.
- At least 5 years' experience in quality management or a similar role.
- In-depth knowledge of ISO 13485 and ISO 9001, as well as regulatory requirements pertaining to product development.
- Understanding of various production/manufacturing processes.
- Excellent verbal and written English communication skills.
About Us:
We are a leading product design team providing comprehensive design services to companies across various industries. We offer a unique opportunity for creative, passionate, professional designers and engineers to continue to develop their skills with us.
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