Senior Quality Engineer

Recruiter: Francisco Munoz Munoz

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At our company, we value diversity and believe it is our greatest strength. We are committed to empowering women, supporting the LGBTQ+ community, and creating opportunities for individuals with disabilities. Our belief is that your diversity enriches our work environment. As an equal opportunity employer, we wholeheartedly welcome applications from all qualified candidates, regardless of their background. Additionally, we have a Gender Equality Policy that reflects our commitment to fairness and equality in the workplace.

About the Role:

The Senior Quality Engineer, IQA is responsible for providing senior Quality Engineering support to Incoming Quality Assurance activities at the Heredia 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.
• For internal candidates: 1 year or more in current position and annual performance evaluation of “Meets Expectations” or “Exceeds Expectations,” if applicable per internal posting requirements.

Requisition ID: 634192

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination, and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.