Site Leader (Director), Operations Quality Assurance-
Core
Lead the Quality function across Pune (Chakan) manufacturing sites to ensure compliance with global regulations and drive operational excellence for medical devices.
Role type
Director, Operations Quality Assurance
Builds
Medical device manufacturing operations compliant with FDA, ISO, and EU MDR standards
Domain
Medical Devices / Manufacturing Quality
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic quality leadership, regulatory compliance (FDA/ISO 13485/MDR), audit management, CAPA and nonconformance resolution, quality system oversight, risk-based decision-making, organizational development
Preferred skills
Advanced degree in Engineering/Quality/Life Sciences, experience leading quality transformation initiatives
Technologies
None stated
Responsibilities
Lead Operations Quality Assurance activities ensuring compliance and patient safety; Develop and execute Operations Quality Strategy; Represent the organization during regulatory inspections and external audits; Drive resolution of audit findings and CAPA activities; Establish and monitor quality metrics and management review processes; Build and develop a high-performing Quality organization
Seniority
Director, strategic and operational leadership