Be a key player in quality assurance for medical devices as a proactive Quality Engineer. Utilize your solid foundation in FDA regulations and validation processes to foster compliance and continuous improvement. This role requires a commitment to quality within a regulated environment, supporting quality systems and leading CAPA initiatives. Engage in cross-functional collaborations to implement process improvements while ensuring adherence to regulatory standards during audits and documentation review. Key Responsibilities: Support quality systems for regulatory compliance Lead CAPA investigations and conduct root cause analysis Maintain, review, and update quality documentation Collaborate with teams for effective process improvements Assist in managing audits and resolving findings promptly Requirements: 3+ years of experience in Quality Engineering for medical devices Strong knowledge in FDA regulatory frameworks and ISO 13485 Experience with CAPA, NCR, and Root Cause Analysis methodologies Hands-on validation experience, including IQ/OQ/PQ Understanding of risk management and documentation procedures Enhance your career by ensuring compliance and driving quality in medical devices, contributing directly to patient safety and satisfaction. #J-18808-Ljbffr
Job Title
Dynamic Quality Engineer Focusing on Medical Device Compliance Strategies