Quality Specialist I/II

Job Summary

A company is looking for a Quality Specialist I/II to manage health and safety-related product complaints.

Key Responsibilities

• Serve as the primary contact for customers reporting health and safety-related complaints
• Document and investigate complaint data, collaborating with cross-functional teams to resolve product issues
• Evaluate complaints for regulatory reportability and support audits and inspections with necessary documentation

Required Qualifications

• 2+ years of Quality Management System (QMS) experience in Medical Device, Pharmaceutical, or Biotechnology industries
• 1+ years in a clinical, customer service, or complaint handling role within regulated healthcare or medical device environments
• Knowledge of medical device regulations (FDA 21 CFR 803/820, ISO 13485, EU MDR)
• Bachelor's degree in nursing, health sciences, biomedical engineering, or a related clinical field; or equivalent experience is preferred
• Experience with eQMS software