Responsibilities Develop quality testing methods, documentation, and test procedures. Implement and maintain quality standards in accordance with ISO 13485 . Manage quality system metrics such as Customer Complaints (CCs), Non-Conforming Material Reports (NCMRs), and Corrective and Preventive Actions (CAPA). Lead and support project and sustaining activities, including test method validations, first article inspections (FAI), product inspections, and material releases. Implement, review, and support Engineering Change Orders (ECOs). Establish detailed quality standards and ensure compliance with organizational quality objectives. Conduct and support internal, external, and customer audits. Define and monitor quality metrics for manufacturing processes. Supervise and manage workload of quality technicians and inspectors, as applicable. Perform inspections of materials and products based on specifications and requirements. Conduct root cause analysis using industry-standard methodologies. Prepare reports on quality issues and corrective actions. Collaborate with cross-functional teams to improve product quality and customer satisfaction. Develop team structures and support the growth and development of team members. Qualifications Bachelor’s degree in Industrial Engineering, Quality Engineering, or related field. Minimum 3 years of experience in QMS within the medical device industry. Strong knowledge of: ISO 13485 CAPA systems Internal and external audits Root cause analysis Quality system documentation Advanced English (required). #J-18808-Ljbffr