Quality Specialist I / II

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