Supervisor, Complaint Processing

About the role

The Supervisor, Complaint Processing leads a global team that handles complaints and inquiries related to medical devices from internal and external customers. The role ensures regulatory compliance, product quality, and customer satisfaction while maintaining the quality system and profitability of the process.

Key responsibilities

• Provide daily direction to analysts processing complaints and anticipate trends.
• Implement policies, procedures, and new product launches affecting the complaint processing department.
• Act as a complaint processing expert during internal and external audits.
• Ensure complaint records meet regulatory requirements and keep the team updated on obligations.
• Lead internal controls to guarantee performance compliance.
• Support other PMQA functions such as intake and reporting.
• Execute quality activities including CAPAs, internal audits, change controls, and procedure updates.
• Develop direct reports using organizational tools.
• Prepare and present product complaint data and drive continuous improvement in data integrity.

Required profile

• Bachelor's degree in a scientific, engineering, or technological field (e.g., chemistry, pharmacy, biology, microbiology).
• Advanced English proficiency (minimum B2 level).
• At least 3 years of experience in a regulated medical device environment (GMP) and quality.
• Minimum 1 year of supervisory experience.
• Experience in project execution.

Required skills

• Knowledge of FDA 21 CFR Part 803 and Part 820.
• Familiarity with EU MDR.
• Understanding of ISO 13485:2016.