Role: Senior Operations Manager - Medical Devices
Education:Graduate in Life Sciences, Pharma, Biotechnology, Biomedical, Mechanical Engineering
Location: Kolkata
Shift: UK shift

Minimum 12-15 years of experience in medical devices industry, preferably in medical devices BPO
8–10+ years of leadership experience managing large-scale global operations.

Roles and Responsibilities
Experience supporting regulatory inspections, audits, CAPA programs, and complaint handling systems.
Lead global end-to-end PQC operations for a team of ~250 resources, ensuring delivery excellence, compliance, and customer satisfaction.

Drive regulatory compliance, audit readiness, CAPA governance, and quality performance across complaint management processes.

Build robust client relationships, manage escalations, and lead strategic governance programs.

Deliver operational transformation through process optimization, AI, automation, analytics,



and continuous improvement initiatives.

Develop high-performing teams while achieving KPI, SLA, financial, and business growth targets.

Proven experience managing PQC, PMS, Vigilance, Quality, or Customer Quality engagements.

Key Area :

• Medical Device Complaint Management
• Product Quality & Complaint Investigation
• Regulatory Compliance (FDA, ISO 13485, MDR)
• CAPA Management (Corrective & Preventive Actions)
• Risk Assessment & Quality Reporting
• Device Vigilance / Post Market Surveillance
• Process Governance & Operations Management
• Client Stakeholder Management
• Team Handling and Delivery Management (for senior roles)
• Continuous Improvement & Automation Initiatives

Public

📌 Senior Operations Manager (Kolkata)
🏢 Wipro
📍 Kolkata