Quality Engineer

Job SummaryWe are looking for a Quality Engineer to support quality and manufacturing activities at Boston Scientific. The ideal candidate will have experience in medical devices, quality systems, manufacturing processes, and regulatory requirements.Key ResponsibilitiesDevelop, implement, and maintain quality processes and procedures.Support manufacturing and production teams in resolving quality issues.Conduct root cause analysis and implement corrective and preventive actions (CAPA).Participate in non-conformance investigations and complaint-related activities.Perform process and product quality assessments.Support validation activities, process improvements, and continuous improvement initiatives.Review and analyze quality data, trends, and performance metrics.Prepare and maintain quality documentation and technical reports.Participate in internal and external audits and ensure compliance with applicable quality standards.Work cross-functionally with Manufacturing, R&D, Regulatory, Operations, and Supplier Quality teams.Ensure compliance with FDA, ISO 13485, and applicable medical-device regulations.Required QualificationsBachelor’s degree in Engineering, Quality, Manufacturing, or a related field.Experience working in a medical device / regulated manufacturing environment preferred.Strong knowledge of Quality Management Systems (QMS).Experience with CAPA, NCR/non-conformance, root cause analysis, and corrective actions.Knowledge of FDA regulations and ISO 13485.Experience with process improvement and quality tools.Strong analytical, problem-solving, documentation, and communication skills.