发布 Dec 18, 2023 328 查看
Reporting To: CEO
Responsibilities:
1. Lead the implementation and maintenance of the Quality Management System (QMS) under ISO 13485:2016 requirements.
2. Conduct regular internal audits to ensure ongoing compliance and identify areas for improvement.
3. Develop, implement, and manage quality assurance policies and procedures to ensure product quality throughout the manufacturing process.
4. Prepare for and participate in external audits and regulatory inspections.
5. Supervise and mentor the QA team, providing guidance and support to ensure the highest level of performance.
6. Identify and assess risks related to product quality and regulatory compliance.
7. Implement effective risk mitigation strategies and monitor their effectiveness.
Education & Experience:
1. Bachelor's degree in a related field (Quality Management, Engineering, or equivalent).
2. Minimum of 2 to 3 years of experience in quality assurance within the medical device industry.
3. In-depth knowledge of ISO 13485:2016 standards and regulatory requirements.
4. Proven experience in leading successful regulatory audits.
5. Strong leadership and communication skills.
6. Detail-oriented with excellent problem-solving abilities.
GB Medical is an equal-opportunity employer and values diversity in the workplace. We encourage applications from individuals of all backgrounds.
GB Medical Instruments
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