Quality Assurance Complaints Specialist

Job description

Are you passionate about quality and compliance in the medical device industry? Euclid Vision Corporation is seeking a hands-on, detail-oriented Quality Specialist to join our team! In this critical role, you’ll be the primary owner of our complaints handling process, ensuring we meet the highest standards for quality and regulatory compliance. What You’ll Do: - Lead the end-to-end complaints handling process: review, assess, document, investigate, and close complaints in a timely and compliant manner. - Analyze complaint data, conduct root cause analysis, and collaborate with cross-functional teams (Quality Assurance, Regulatory Affairs, Operations) to resolve issues and drive improvements. - Monitor complaint trends and escalate reportable events as needed. - Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and other applicable regulations. - Support internal and external audits, and participate in CAPA (Corrective and Preventive Action) activities. - Review and revise procedures to maintain regulatory compliance and meet customer requirements. - Assist with non-conformance reviews, management review meetings, and KPI reporting. What We’re Looking For: - Bachelor’s degree O...