Quality Engineer III

DUTIES: Responsible for ensuring product and process quality across manufacturing operations, exercising independent authority over critical quality decisions, and driving continuous improvement in compliance with applicable regulatory and industry standards. Identify and resolve complex exceptions to work assignments; summarize, analyze, draw conclusions, and make appropriate decisions based on test results and other process-related findings; and read and interpret technical drawings, procedures, and protocols. Identify manufacturing process defects (scrap, non-conforming material, and customer complaints) by dispositioning non-conforming material, assisting in the identification of primary root causes, and developing corrective and preventive actions. Exercise independent authority to make decisions related to product quality, including the disposition of non-conforming product, and participate in the investigation of customer complaints for areas under the position's control. Drive improvements in product and process quality, including checking and providing support in the execution and investigation of CAPAs, NCEPs, Failure Mode Investigations, and related activities. Evaluate new equipment and processes and participate in the transfer of new products, apply knowledge of QSR and ISO standards while promoting awareness of best industry practices and making appropriate quality decisions on a daily basis, and apply knowledge of validation techniques and associated regulatory requirements, including the analysis of customer feedback and complaints. Review and develop process validation protocols and report and support other functional areas during validation activities. Evaluate new equipment, processes, and chemicals for environmental impact in order to eliminate or lessen such impacts, and apply knowledge of Risk Management and ISO 14971 requirements. Compile and analyze operational, test, and validation data to establish technical specifications and performance standards for newly designed or modified products and processes; participate directly in new product/technology transfers to ensure compliance with all internal and regulatory requirements; and apply knowledge of Six Sigma, statistical analysis, and Lean principles to investigate and solve problems and improve quality. Ensure that all laboratory equipment is in compliance to perform analysis activities (calibration, safety, and cleanliness). Provide technical guidance to other Quality Engineers, Technicians, and Inspection staff, and serve as a motivated team member committed to achieving and demonstrating best practices in line with departmental and site objectives. Interact with suppliers, other engineering disciplines within and outside the site, and customers as needed, and maintain familiarity with the internal auditing process. May require to travel/telecommute. REQUIREMENTS: Employer requires a Bachelors degree or foreign equivalent in Production Engineering, Industrial Engineering, or a related field plus 48 months of experience in job offered or related occupation. Experience must include: 1) Quality management system 2) Industrial Design 3) Design Control 4) Failure Mode Effective Analysis; 5) Production and Process Control 6) Risk Management 7) Supplier Quality Management 8) Audit management 9) Engineering change assessment 10) Regulatory requirements 11) Sterilization process expertise. WORKSITE: 8 Industrial Drive, Coventry, RI 02816 SALARY: From $127,275 to $145,125 per year CONTACT: Susan Cardinal, Boston Scientific Corporation, (email removed). Must include reference H4. Boston Scientific offers medical & dental coverage, well-being support, & 401K plan (EOE).