Senior Quality Engineer, IQA.

Additional Locations: Cartago

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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 use, including calibration, safety, cleanliness, documentation, and readiness for inspection activities.

· Provide technical guidance, coaching, and support to Associate Quality Engineers, Quality Technicians, inspection personnel, and other team members within the IQA process.

· Promote audit readiness by ensuring documentation is complete, objective, traceable, and aligned with Boston Scientific procedures and applicable regulatory expectations.

· Collaborate effectively with internal customers, other engineering disciplines, supplier quality, manufacturing, sustaining teams, and site/global stakeholders to support operational priorities and product quality.

· Participate in internal audits, quality system assessments, and remediation activities as needed, applying best industry practices and escalating critical quality decisions appropriately.

What We’re Looking For:

· Bachelor’s degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering, or a related technical field.

· Minimum of 5 years of experience in Quality Engineering, Incoming Quality Assurance, Supplier Quality, Manufacturing Quality, Process Quality, or a similar regulated medical device environment.

· English level required: B2+ preferred, with ability to communicate technical and quality information clearly across functions and sites.

· Strong knowledge of quality system requirements, including QSR, ISO 13485, CAPA, nonconformance management, risk management, validation, inspection techniques, and documentation practices.

· Experience with root cause analysis, problem solving, statistical and quality techniques, inspection method controls, sampling plans, process capability, SPC, Gage R&R, DOE, Six Sigma, Lean, APQP or similar tools is preferred.

· Experience supporting product transfers, component qualification, supplier-related quality activities, validation activities, and cross-functional quality investigations is strongly preferred.

· Demonstrated ability to make risk-based quality decisions, manage complex technical issues, communicate effectively with stakeholders, and provide technical guidance to others.

· ASQ certification such as CQE and/or Six Sigma Green Belt is desirable.

Requisition ID: 631910

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.