Site Leader (Director), Operations Quality Assurance-

Job Title

Site Leader (Director), Operations Quality Assurance-

Job Description

The Site Leader (Director), Operations Quality Assurance is responsible for leading the Quality function across the Pune (Chakan) manufacturing sites. This role provides strategic and operational leadership to ensure all medical devices, manufacturing processes, and quality system activities comply with applicable regulatory requirements, Philips standards, and business objectives.

Your Role:

- Lead all Operations Quality Assurance activities across the Pune (Chakan) manufacturing sites, ensuring compliance, product quality, patient safety, and operations quality performance.

- Accountable for developing and executing the Operations Quality Strategy, translating enterprise quality objectives into measurable site-level priorities/results, driving a culture of quality and compliance, ensuring inspection readiness, and continuously improving quality performance across the sites.

- As the senior Quality leader and designated Quality Management Representative, the Director represents the organization during regulatory inspections/external audits, ensures the effectiveness and compliance of the Quality Management System and partners closely with Operations, R&D, Regulatory Affairs, Supply Chain, and Business Leadership to ensure product quality, patient safety, and business continuity.

- Ensure all products, manufacturing processes, and quality system activities comply with FDA regulations, ISO 13485, ISO 14971, MDSAP, EU MDR, and other applicable global requirements.

- Lead and represent the sites during FDA inspections, Notified Body audits, customer audits, and regulatory authority interactions, maintaining a continuous state of inspection readiness.

- Drive timely resolution of audit findings, compliance gaps, nonconformances, and CAPA activities through robust root cause analysis and sustainable corrective actions.

- Provide leadership for Manufacturing Quality, Quality Systems, CAPA, Nonconformance Management, Validation Quality Oversight.

- Establish and monitor quality metrics and management review processes to identify risks, improve performance, and ensure quality system effectiveness.

- Drive a strong culture of quality, compliance, accountability, continuous improvement, and operational excellence throughout the organization.