QA Manager

Role: QA Manager within the Medical Device/Software industry, responsible for maintaining and improving the Quality Management System (QMS) to ensure compliance with FDA, EU, ISO 13485, and MDSAP regulations. Responsibilities: oversee document control, complaint management, CAPA, training, and post-market activities; lead investigations of nonconformities; support audits; develop and review quality documentation; participate in risk assessments and process improvements; ensure audit readiness and regulatory compliance. Requirements: Bachelor's degree; at least 7 years of QA experience in regulated industries, preferably with SaMD; solid understanding of QMS standards such as FDA CFR 21 820, ISO 13485, and MDSAP; proven leadership and team management skills; effective cross-functional collaboration. Preferred: experience in medical devices or pharmaceuticals, root cause analysis expertise, strong influencing and communication skills, ability to manage multiple priorities, and thrive in dynamic environments. High-Value: focus on Medical Devices/Software, regulatory compliance, risk management, audit support, and industry best practices. WorkSetup: U.S. based, no relocation assistance, legal authorization required.