Quality System Engineer

<p><strong>Key Responsibilities:</strong></p><ul><li>Support implementation of internal quality system requirements and external regulatory standards (e.g., FDA, ISO 13485, cGMP, EU MDR)</li><li>Drive improvements to procedures and standards to enhance efficiency while maintaining compliance</li><li>Support and coordinate CAPA and compliance programs, including facilitating CAPA activities across functions</li><li>Participate in CAPA management activities and global quality system discussions</li><li>Conduct internal audits to identify gaps, ensure compliance, and drive continuous improvement</li><li>Support audit readiness, including front-room and back-room activities during external audits and inspections</li><li>Deliver quality system training and guidance to employees across the site</li><li>Lead or participate in system and process improvement initiatives using structured problem-solving approaches</li><li>Identify areas of non-compliance and recommend corrective actions to improve overall quality system effectiveness</li><li>Provide quality support and oversight for compliance investigations (e.g., non-conformance, OOS/OOT), where applicable</li></ul><p> </p><p><strong>Requirements:</strong></p><ul><li>Bachelor’s Degree in Science, Engineering, or a related field</li><li>2–5 years of experience in a manufacturing environment</li><li>Experience in the medical device industry is desirable</li><li>Experience in: Non-conformance and CAPA management; Management Review processes; Internal and external audits</li></ul><p> </p><p><strong>Required Skills & Knowledge:</strong></p><ul><li>Knowledge of ISO 13485, EU MDR, and FDA regulations</li><li>Knowledge of cGMP and combination product/device regulations</li></ul><p>About Us</p><p>As a global medical technology leader for more than 45 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.</p>