Boston Scientific · 1 month ago
Supplier Quality Engineer II
Carlsbad, CA
Full-time
Onsite
Mid, Senior Level
$73K/yr - $138K/yr
5+ years expBoston Scientific is a leader in medical science committed to solving important health industry challenges. They are seeking an experienced Supplier Quality Engineer to lead supplier quality initiatives, manage supplier performance, and ensure compliance with internal procedures and global regulatory requirements.
Health CareMedicalMedical Device
No H1B
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
Qualification
Required
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
Preferred
Certified Quality Engineer (CQE), Lead Auditor certification, or Six Sigma certification
Familiarity with global supply chains and international supplier regulatory expectations
Company
Boston Scientific
Boston Scientific is a medical technology company that designs and develops medical devices to diagnose and treat a wide range of condition.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$10.02B2025-02-21Post Ipo Debt· $1.58B
2024-02-22Post Ipo Debt· $2.17B
2022-03-04Post Ipo Debt· $3.28B
Leadership Team
Michael Mahoney
Chairman, President & CEO
Daniel J. Brennan
Chief Financial Officer
Recent News
2026-01-18
Company data provided by crunchbase