Complaint Processing Supervisor

About the role

The Complaint Processing Supervisor will lead a local team of analysts responsible for handling internal and external complaints related to medical devices. This position ensures regulatory compliance, product quality, and customer satisfaction while supporting continuous improvement across the complaint lifecycle.

Key responsibilities

• Provide daily direction and coaching to analysts processing complaints.
• Monitor trends and anticipate emerging issues.
• Implement policies, procedures, and new product launches affecting complaint handling.
• Act as the subject‑matter expert during internal and external audits.
• Maintain accurate complaint records and ensure alignment with regulatory obligations.
• Lead internal controls, CAPA execution, change controls, and documentation practices.
• Prepare and present complaint data and performance metrics.
• Support other PMQA functions such as intake and reporting as needed.

Required profile

• Bachelor’s degree in a scientific or engineering field (e.g., chemistry, pharmacy, biology, microbiology).
• Minimum three years of experience in a regulated medical‑device environment (GMP).
• At least one year of supervisory experience.
• Proven ability to manage projects and drive continuous improvement.
• Advanced English proficiency (minimum B2 level).

Required skills

• Knowledge of FDA 21 CFR Part 803 and Part 820.
• Familiarity with EU MDR requirements.
• Understanding of ISO 13485:2016 standards.
• Experience with GMP‑based quality systems.