Supplier Quality Engineer II

Boston Scientific•Carlsbad, CA

35d•$72,800 - $138,300•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

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

Responsibilities

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 nonconforming 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.