Supplier Quality Engineer II

About The Role

Boston Scientific is seeking an experienced and driven Supplier Quality Engineer (SQE) to lead supplier quality initiatives, manage supplier performance, and ensure compliance with both internal procedures and global regulatory requirements. This role is vital to establishing and maintaining a robust supply base that supports product excellence, patient safety, and long‑term business success.

• Evaluate and qualify new suppliers through audits, assessments, and technical reviews.
• Monitor supplier performance using key performance indicators (KPIs) such as parts per million (PPM), on‑time delivery, and quality metrics.
• Lead investigations related to non‑conforming materials or components, including root cause analysis and implementation of corrective actions.
• Conduct supplier audits (remote and on‑site) and support ongoing supplier development initiatives.
• Manage Supplier Corrective Action Requests (SCARs) and ensure timely, effective resolution.
• Collaborate with Procurement, Engineering, and Manufacturing teams to address supplier‑related issues and enhance quality outcomes.
• Develop, implement, and maintain supplier quality agreements in accordance with applicable standards and regulations (e.g., ISO 13485, FDA QSR, EU MDR, ISO 14971).
• Support incoming inspection processes and define acceptance criteria for critical components and materials.
• Maintain accurate documentation and records in compliance with regulatory and internal requirements.
• Perform other duties as assigned.

• Bachelor’s degree in Engineering, Quality, or a related field.
• Minimum of 5 years’ experience in supplier quality or manufacturing quality in a regulated industry.
• Strong working knowledge of quality management systems and regulatory standards including ISO 13485, FDA QSR, EU MDR, and ISO 14971.
• Hands‑on experience with root cause analysis tools such as 5 Whys, Fishbone, and 8D, as well as CAPA processes.
• Familiarity with inspection techniques, metrology, and statistical quality control methods.
• Excellent communication, negotiation, and cross‑functional problem‑solving skills.

• Certified Quality Engineer (CQE), Lead Auditor certification, or Six Sigma certification.
• Familiarity with global supply chains and international supplier regulatory expectations.

Minimum Salary: $72,800
Maximum Salary: $138,300

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

• Some U.S. based positions may require proof of COVID‑19 vaccination status.
• Some safety‑sensitive positions require a prohibited substance test.