Quality Engineer

Job description

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