Quality Assurance Executive

1. Lead and manage a team of quality assurance professionals, providing guidance, coaching, and development opportunities.

2. Foster a culture of quality and compliance within the team and across the organization.

3. Develop, implement, and maintain quality assurance systems, processes, and procedures in accordance with regulatory requirements and industry standards (e.g., ISO 13485, FDA 21 CFR Part 820).

4. Ensure quality systems are aligned with business objectives and industry best practices.

5. Stay up-to-date with changing regulatory requirements and industry standards, ensuring the company's quality systems remain compliant.

6. Collaborate with cross-functional teams to ensure regulatory requirements are integrated into product development, manufacturing, and distribution processes.

7. Develop and implement audit plans, conducting internal audits to ensure compliance with quality systems and regulatory requirements. 

8. Prepare for and respond to external audits and inspections from regulatory agencies, notified bodies, and customers.

9. Develop and implement CAPA processes to address quality issues, deviations, and non-conformities.

10. Ensure CAPA effectiveness and closure, driving continuous improvement.

11. Identify, assess, and mitigate quality-related risks, ensuring risk management processes are integrated into quality systems.

12. Develop and deliver training programs for quality assurance personnel and other stakeholders, ensuring awareness of quality systems, procedures, and regulatory requirements.

13. Drive continuous improvement initiatives, leveraging quality metrics, trend analysis, and industry best practices.

MAIL YOUR RESUME AT HR@DRODIN.IN