Project Manager – CAPA & Complaints

About the 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.

Key responsibilities

• Coordinate implementation of corrective and 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.

Required profile

• Bachelor's or Master's degree in Mechanical/Electronics Engineering.
• 10+ years of project management experience, preferably with CAPA and complaints handling in medical devices.
• Strong knowledge of Quality Management Systems and risk‑management principles.
• Strong data analytics skills with the ability to derive insights from operational data.
• Excellent stakeholder management and communication across multiple organizational levels.
• Proven ability to drive accountability and coordinate cross‑functional teams without direct authority.
• Experience in process improvement, operational excellence, and AI‑enabled productivity solutions (preferred).
• Proficiency with project management tools.

Required skills

• Data analytics
• Project management tools