Senior Quality Engineer, IQA.

Additional Locations: Cartago Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions. Engineer Sr, Quality / Senior Quality Engineer, IQA.   About the Role: The Senior Quality Engineer, IQA is responsible for providing senior Quality Engineering support to Incoming Quality Assurance activities at the Cartago site, ensuring patient safety, product quality, regulatory compliance, and continuity of IQA operations. This role supports incoming inspection, material disposition, supplier/component quality, nonconformance investigations, CAPA/NCEP activities, validation and transfer-related activities for sustaining operations. The position is expected to make sound, risk-based quality decisions, provide technical guidance to IQA personnel, and partner with cross-functional teams to maintain an effective quality system and support business continuity across multiple Business Units and transfer activities.   Your Responsibilities Include:   · Demonstrate commitment to the Quality Policy through daily execution of sound quality practices, patient safety focus, and maintenance of an effective quality system. · Provide senior Quality Engineering support for Incoming Quality Assurance operations, including incoming inspection processes, material acceptance activities, and IQA laboratory controls. · Exercise independent authority to make decisions related to product quality and material inspection, including disposition of nonconforming product/material within the applicable quality system requirements. · Identify, investigate, and resolve complex quality issues related to nonconforming raw materials, components, finished goods, inspection findings, transfer activities, supplier issues, and customer complaints, as applicable. · Summarize, analyze, draw conclusions, and make appropriate risk-based decisions from inspection results, test results, validation data, operational data, and other process-related findings. · Lead or support investigations for NCMRs, CAPAs, NCEPs, Failure Mode Investigations, customer complaints, and other quality events by documenting objective evidence, root cause analysis, containment, corrective actions, and preventive actions. · Read, interpret, and apply technical drawings, specifications, procedures, protocols, inspection methods, quality plans, and applicable quality system documentation. · Support product transfers, in-country transfers, new component qualification, inspection method implementation, and process/equipment changes to ensure compliance with internal and regulatory requirements. · Review, develop, and/or approve process validation protocols, inspection/test method documentation, reports, and related quality records in partnership with Manufacturing, Engineering, Supplier Quality, R&D, and other functional areas. · Apply knowledge of QSR, ISO 13485, risk management principles, validation requirements, statistical methods, Six Sigma, Lean, APQP or similar quality tools to solve problems and drive continuous improvement. · Work with suppliers, process owners, and cross-functional partners to support component qualification, statistical sampling plans, inspection methodology, quality procedures, and release criteria as needed. · Monitor quality trends, inspection performance, nonconformance data, and other relevant metrics to identify opportunities to reduce variation, improve inspection effectiveness, and strengthen process controls. · Assure that IQA laboratory equipment and inspection tools are compliant for