Quality Assurance Manager
1 week ago
The quality assurance manager plays a crucial role in driving our organization's commitment to excellence, ensuring the highest standards of quality are maintained throughout all operations.
- Develop and implement comprehensive audit programs and plans, conduct internal audits, and coordinate external audits to ensure regulatory compliance.
- Identify and document opportunities for process improvement, working collaboratively with subject matter experts to drive implementation and achieve tangible results.
- Manage CAPA related activities efficiently, ensuring prompt identification and resolution of any nonconformities or product defects.
Key Responsibilities
- Lead the facilitation of risk management practices aligned with industry best standards, including ISO 14971, IEC 60812, and ISO 31000, to safeguard product safety and user needs.
- Ensure accurate records of product requirements verification and validation activities, promoting traceability throughout development.
- Oversee quality assurance for medical device development in accordance with CE MDR, FDA, and TGA regulations, as well as ISO 13485, IEC 60601, and IEC 62304 standards.
- Establish and maintain a calibration program for test and measurement equipment, guaranteeing accuracy and precision in testing processes.
- Source and evaluate suppliers, monitor quality agreements, and address actions arising from goods inspection.
- Design and deliver induction training on quality management systems processes and policies, and promote QMS regulatory requirements among staff members.
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