Site Leader (Director) – Operations Quality Assurance

About the role

The Site Leader (Director), Operations Quality Assurance will lead the Quality function across Philips' manufacturing sites in Pune (Chakan). This senior position ensures that medical devices, processes and quality systems meet regulatory requirements, Philips standards and business goals while fostering a culture of compliance and continuous improvement.

Key responsibilities

• Develop and execute the Operations Quality Strategy, translating enterprise objectives into measurable site‑level priorities.
• Represent the organization as Quality Management Representative during FDA inspections, Notified Body audits and customer audits, maintaining inspection readiness.
• Drive resolution of audit findings, non‑conformances and CAPA activities through root‑cause analysis and sustainable corrective actions.
• Lead Manufacturing Quality, Quality Systems, CAPA, Non‑conformance Management and Validation oversight.
• Establish and monitor quality metrics, risk assessments and management review processes to improve performance.
• Partner with Operations, R&D, Regulatory Affairs, Supply Chain and Business Leadership to ensure product quality, patient safety and business continuity.

Required profile

• 15+ years of progressive leadership experience in FDA‑regulated medical device manufacturing.
• Proven track record in quality transformation, remediation, compliance improvement or operational excellence initiatives.
• Experience serving as a Quality Management Representative and leading organizations through regulatory inspections.
• Strong influencing, collaboration and change‑management skills with executive presence.
• Bachelor’s degree in Engineering, Quality, Life Sciences or related field; advanced degree preferred.

Required skills

• In‑depth knowledge of FDA regulations, ISO 13485, ISO 14971, MDSAP and EU MDR.
• Expertise in CAPA, Non‑conformance Management and Validation processes.
• Ability to develop and use quality metrics and risk‑based decision‑making tools.