Site Leader Quality Operations

Acute Care Technology

This position is responsible for the overall leadership and execution of the quality assurance and quality control strategy, programs and policies for a ZOLL manufacturing site. Oversee multiple shifts for Quality support to meet the daily, weekly, and monthly requirements for Production Schedule and customer attainment.

Essential Functions:

1. Implement, improve and maintain an effective QMS that complies with relevant regulations and industry standards, such as ISO 13485 and FDA requirements.
2. Collaborate with other ACT quality site leads to ensure the integrated QMS is functioning as intended at the site level and across sites.
3. Lead efforts to continuously improve quality system processes and procedures to enhance product quality, reduce defects, and increase customer satisfaction.
4. Responsible for leading facility internal and external audits to a successful outcome.
5. Prepares and attends Quarterly Management Review and QA staff meetings.
6. Provide leadership, guidance, and mentorship to the quality assurance team, including hiring, training, performance management, and professional development.
7. Promote a culture of quality throughout the organization by providing training, guidance, and support to all employees, and by fostering a proactive and accountable approach to quality and regulatory compliance.
8. Ensure that new products and changes to existing products are implemented in accordance with the organization\'s Quality Management System.
9. Work with Quality Engineering resources to complete investigations into product non-conformances and customer complaints, implement appropriate corrective and preventive actions (CAPAs), and track their effectiveness.
10. Provide guidance on validation activities, including approach, sampling plans, and deviation resolution. Delegation of protocol and report approvals.
11. Support the risk management program and practices to identify and mitigate potential risks associated with product quality.
12. Develop and implement robust quality control processes to monitor and evaluate product quality, ensuring adherence to specifications and standards.
13. Develops and prepares weekly/monthly/quarterly/annual reporting on Quality KPIs, support and improvement activities
14. Stay up-to-date with relevant regulations and standards in the medical device industry, and ensure the site\'s compliance with all applicable regulations, including FDA, EU MDR, and other global regulatory requirements.
15. Establishes annual improvement/Quality Objectives for the site in coordination with other site leads.
16. Conduct annual and ongoing performance reviews with recommendations for compensation changes, promotions, and disciplinary action as appropriate.
17. Set a professional example in alignment with ZOLL\'s Leadership Qualities.
18. Comply with all policies and standards.
19. Any other job responsibilities as assigned by management and subject...