Quality Assurance Manager

Are you an experienced Quality leader with a strong background in medical device manufacturing, ISO 13485, FDA compliance, and Quality Management Systems ? We're partnering with an innovative manufacturer seeking a Senior Quality Assurance Manager to lead Quality strategy, regulatory compliance, and continuous improvement initiatives across the organization. This is an excellent opportunity to make a significant impact while leading a talented quality team in a highly regulated manufacturing environment. What You'll Do Lead and continuously improve the company's Quality Management System (QMS). Ensure compliance with ISO 13485, FDA 21 CFR Part 820/QMSR, ITAR, and customer requirements. Oversee CAPA, nonconformances, customer complaints, audits, validations, and regulatory compliance. Serve as the primary Quality representative during customer, certification, and regulatory audits. Lead, mentor, and develop the Quality team while partnering with Engineering, Manufacturing, and Operations. Drive continuous improvement initiatives that enhance product quality, compliance, and operational performance. What We're Looking For 8+ years of Quality experience in a regulated manufacturing environment Leadership experience managing Quality teams Strong experience with: ISO 13485 FDA 21 CFR Part 820 / QMSR CAPA Internal & External Audits Validation (IQ/OQ/PQ) Quality Management Systems Medical device manufacturing experience ASQ Certification (CQE/CQA) or Six Sigma #J-18808-Ljbffr