Site Leader (Director), Operations Quality Assurance-

Job description

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. Partner with Operations and cross-functional leadership to proactively identify and mitigate quality risks while supporting business growth and product realization. Lead quality transformation, remediation, and continuous improvement initiatives to strengthen compliance, process capability, and customer satisfaction. Build and develop a high-performing Quality organization through talent management, succession planning, coaching, and organizational development. You're the Right Fit If: You have 15+ years of progressive leadership experience in FDA-regulated medical device manufacturing environments. You have demonstrated leadership across Quality Systems, Manufacturing Quality, Supplier Quality, CAPA, Nonconformance Management, Validation, Product Release, and Continuous Improvement. You possess deep knowledge of FDA regulations, ISO 13485, ISO 14971, MDSAP, EU MDR, and global medical device quality requirements. You have experience serving as a Quality Management Representative and leading organizations through regulatory inspections and external audits. You have successfully led quality transformation, remediation, compliance improvement, or operational excellence initiatives. You have strong experience using quality metrics and business performance indicators to drive risk-based decision-making and continuous improvement. You are an effective strategic and operational leader with strong influencing, collaboration, communication, and change management skills. You demonstrate executive presence and are comfortable engaging with senior leadership, auditors, regulators, and external stakeholders. You have a Bachelor's degree in Engineering, Quality, Life Sciences, or a related technical field. An advanced degree is preferred. You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position . How we work together: We believe that we are better together than a part. For our office-based teams, this means working in-person at least 4 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is an Office-Based role. 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