Senior Quality Engineer

Job description

**Key Responsibilities:** - Lead structured problem-solving and provide sound engineering and quality recommendations - Interpret technical drawings, procedures, and specifications to ensure compliance - Make quality-related decisions, including disposition of non-conforming products - Investigate manufacturing defects, non-conformances, and customer complaints; identify root causes and implement effective CAPA - Support and lead quality investigations, including complaint handling and failure analysis - Review and approve validation, operational, and test data to ensure compliance with specifications - Drive continuous improvement initiatives across the product lifecycle - Provide guidance and technical mentorship to junior team members - Collaborate with cross-functional teams, suppliers, and stakeholders to resolve quality issues - Support internal audits and ensure compliance with regulatory and quality system requirements **Requirements:** - Bachelor’s Degree in Science, Engineering, or related field - Minimum 9 years of experience in a manufacturing environment, with strong exposure to operations quality - Experience in the medical device industry is preferred - Experience managing direct reports or in a people management role is an added advantage **Required Skills & Competencies:** - Good interpersonal, problem-solving, and communication skills - Experience in process validation and strong leadership capability - Proven ability to resolve issues using structured problem-solving tools, supported by strong knowledge in quality operations, including product risk assessment and data analysis - to identify root causes and implement corrective actions - Good understanding of ISO 13485 and QMSR (or equivalent regulatory requirements) - Experience leading non-conforming event risk assessments and investigations - Exposure to project management or involvement in cross-functional projects is an added advantage 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.