Senior/QA Engineer (Medical Device)

Job Description

Key Responsibilities • Monitor product and process quality, investigate non-conformances, and implement corrective and preventive actions (CAPA). • Ensure compliance with FDA, ISO 13485, and company quality management system requirements. • Support internal audits, external audits, and regulatory inspections. • Participate in product transfers, new product introductions (NPI), and validation activities (IQ/OQ/PQ, process and test method validation). • Conduct root cause analysis and drive continuous improvement initiatives to enhance quality and manufacturing performance. • Manage customer quality issues, complaints, and change notifications. • Maintain quality documentation, reports, and traceability records. • Train and support manufacturing teams on quality standards and best practices. Show More