Quality Engineer

<p><strong>Key Responsibilities:</strong></p><ul><li>Develop and maintain effective quality systems, process controls, and methodologies to ensure compliance with regulatory, customer, and internal requirements</li><li>Support manufacturing quality activities, including product qualification, process validation, and ongoing improvement initiatives</li><li>Identify, analyze, and resolve product and process quality issues using structured problem-solving and data analysis</li><li>Lead or support investigations on nonconforming products, customer complaints, and manufacturing defects; implement corrective and preventive actions (CAPA)</li><li>Review and develop validation and test protocols; execute qualification and validation activities with proper documentation</li><li>Participate in new product introductions, technology transfers, and evaluation of new equipment and processes</li><li>Ensure compliance with Quality Management Systems (QMS) and applicable regulations (e.g., ISO13485, QSR)</li><li>Collaborate cross-functionally with engineering, operations, suppliers, and customers to resolve quality-related issues</li><li>Analyze operational and validation data to support decision-making and continuous improvement initiatives</li><li>Provide technical guidance or mentorship to junior engineers, technicians, or inspectors where applicable</li><li>Support internal and external audits and maintain effective quality system documentation</li></ul><p><br><strong>Requirements:</strong></p><ul><li>Bachelor’s Degree in Science or Engineering</li><li>3 to 8 years of experience in manufacturing and operations quality</li><li>Experience in the medical device industry is preferred</li><li>Experience in people management is an advantage</li></ul><p><br><strong>Required Skills:</strong></p><ul><li>Strong problem-solving skills with experience in root cause analysis and quality tools</li><li>Good understanding of Quality Management Systems and regulatory standards (e.g., ISO13485, QSR)</li><li>Experience handling nonconformance investigations and product risk assessments</li><li>Ability to analyze data and make sound quality decisions</li><li>Strong communication skills with ability to clearly present findings</li><li>Ability to work effectively in a cross-functional manufacturing environment</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><p><span style="font-size: 14.0px;"><span style="color: #7f8c8d;"> </span></span></p>