R 19756 in Pune

Job Title Project Manager – CAPA & Complaints Job Description Project Manager – CAPA & Complaints Your Role: Coordinate teams across Quality, R&D, Engineering, Manufacturing, Operations, Supply Chain, Procurement, Regulatory, Service and Customer Quality. Identify recurring CAPA themes and opportunities for systemic improvement. Coordinate implementation of corrective/preventive actions, including process, product, system and documentation changes. Maintain CAPA dashboards and management reporting. Drive accountability across CAPA action owners. Own and track business KPIs related to complaint and investigation timelines, quality, and throughput. Provide regular KPI, progress, and risk updates to leadership and key stakeholders. Drive timely closure of complaints and investigations through structured follow-up with action owners. You're the Right Fit If: Bachelor's or Master's degree in Mechanical/Electronics Engineering Experience: 10+ years in Project Management , preferably with CAPA and Complaints Handling in Medical Devices. Strong knowledge of Quality Management Systems and risk-management principles. Skills : Strong data analytics skills with the ability to derive insights from operational and performance data. Excellent stakeholder management and communication skills across multiple organizational levels. Strong presentation and reporting capabilities, including development of executive-level dashboards and updates. Proven ability to drive accountability and coordinate cross-functional teams without direct authority. Experience in process improvement, operational excellence, and AI

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