
Quality Management Specialist
2 weeks ago
We seek a seasoned Quality Manager to spearhead our Quality Management processes and team.
You will develop strategies for continuous improvement, drive the implementation of quality systems and ensure compliance to regulatory standards. Your responsibilities will include:
Audit Programs and Planning
Develop comprehensive audit programs, manage internal audits, and coordinate external audits to verify quality system effectiveness.
Process Improvement
Identify areas for improvement in company processes and systems, collaborate with subject matter experts to drive implementation, and oversee CAPA activities.
Regulatory Compliance
Maintain up-to-date knowledge of applicable standards and regulations across global markets, facilitate risk management in accordance with best practices, and ensure product development meets regulatory requirements.
Product Development and Quality Assurance
Manage quality throughout the development lifecycle, ensuring compliance to regulatory standards such as CE MDR, FDA, and TGA, as well as relevant ISO and IEC standards.
Training and Awareness
Develop and deliver training on quality management processes and policies, promoting regulatory awareness among staff members.
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Senior Software Quality Assurance Specialist
2 weeks ago
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