Quality engineer

Job TitleLead design transfer and production support activities, ensuring compliance with FDA/ISO 13485 and alignment with manufacturing readiness.Own multiple subassemblies for a surgical robotics platform, ensuring design integrity, quality, and manufacturability.Investigate Non-Conformances (Company) using root cause analysis and drive CAPA within the QMS framework.Develop and maintain FMEAs, support risk mitigation, and lead manufacturing issue resolution and qualifications (IQ/OQ/PQ).Identify and implement compliant, alternative solutions to engineering and production challenges while driving continuous improvement.Support and maintain Quality Management System (QMS) processes in compliance with regulatory requirements.Collaborate with cross-functional teams to deliver quality-compliant outcomes.Interpret and apply medical device regulations and standards to projects and processes.Support audits and regulatory inspections, ensuring timely closure of action items.Education & Experience:5+ years of experience in Medical Device Quality & Compliance, with strong knowledge of ISO 13485, 21 CFR 820, MDD/MDR.Hands-on experience in:Quality Management Systems (QMS)Complaint ManagementPost Market Surveillance (PMS)Non-Conformance (NC)Corrective and Preventive Action (CAPA)AuditsStrong expertise in Risk Management (ISO 14971), including FMEA and data-driven quality decision-making.