Back to search
- Conduct internal audits of manufacturing processes, documentation, and quality control systems to ensure compliance with ISO 13485, FDA regulations, and other applicable standards.
- Prepare and maintain audit reports, documenting findings, non-conformances, and corrective actions.
- Work with quality and production teams to implement corrective and preventive actions (CAPAs) and ensure continuous improvement.
- Assist in external audits conducted by regulatory bodies and customers.
- Ensure that all employees adhere to Good Manufacturing Practices (GMP) and company policies.
- Provide training and support to teams on quality systems and regulatory requirements.
- Stay updated on industry regulations, changes in compliance requirements, and best practices.
- Proven experience as a Quality Auditor in a medical devices manufacturing environment.
- Strong knowledge of ISO 13485, FDA regulations, and GMP.
- Experience conducting internal and external audits.
- Excellent analytical skills with attention to detail.
- Strong communication and reporting skills.
- Certification in auditing (e.g., Lead Auditor qualification) is a plus.
- Ability to work collaboratively and independently in a fast-paced environment.
