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 act
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Role overview
Job description
Join Delphi - Where Innovation meets transformation At Delphi, we believe in creating an environment where our people thrive. Our hybrid work model empowers you to choose where you work—whether it's from the office, your home, or a mix of both—so you can prioritize what matters most. We are committed to supporting your personal goals, family, and overall well-being while driving transformative results for our clients. We welcome exceptional talent from anywhere across the globe. Interviews and onboarding are conducted virtually, reflecting our digital-first mindset. Rooted in the region, we specialize in delivering tailored, impactful solutions in Data, Advanced Analytics and AI, Infrastructure, Cloud Security, and Application Modernization. Whether it’s enabling predictive analytics , transforming operations with automation, or driving customer engagement with intelligent platfor
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Skills & requirements
Department · Data Digital & AI Synergy (DDAIS)
Hiring company
Delphi Consulting
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