Quality Engineer, CAPA

Boston Scientific•Carlsbad, CA

36d•$72,800 - $138,300•Onsite

About The Position

Boston Scientific is seeking an experienced and strategic Quality Engineer to serve as the CAPA program owner and drive continuous improvement across the organization. This high-impact role will lead root cause investigations, implement effective corrective and preventive actions (CAPAs), and ensure compliance with regulatory and quality standards. You'll collaborate cross-functionally and influence process enhancements that strengthen our Quality Management System.

Requirements

Bachelor's degree in Engineering, Life Sciences, or a related field.
Minimum of 5 years' experience in Quality Engineering, preferably in a regulated industry (e.g., medical devices or pharmaceuticals).
Proven experience managing CAPA processes and leading root cause investigations.
Strong understanding of regulatory requirements including FDA QSR, ISO 13485, ISO 14971, and EU MDR.
Proficiency with quality tools and methodologies such as Six Sigma, Lean, and Kaizen.
Experience with electronic Quality Management Systems (eQMS), such as TrackWise or similar platforms.
Excellent communication, documentation, and project management skills.

Nice To Haves

Certified Quality Engineer (CQE), Six Sigma Green or Black Belt, or similar certification.
Experience in complaint handling, nonconformance investigations, and post-market surveillance.

Responsibilities

Serve as the CAPA program owner, managing all phases of the CAPA lifecycle from initiation to closure.
Lead or support complex root cause investigations using structured problem-solving tools such as 5 Whys, Fishbone diagrams, 8D, and FMEA.
Facilitate cross-functional teams to identify, analyze, and eliminate root causes of quality issues.
Partner with Engineering, Manufacturing, Regulatory, and Operations to develop and implement robust corrective and preventive actions.
Monitor CAPA effectiveness, track metrics, and identify quality trends and opportunities for improvement.
Ensure CAPA documentation complies with ISO 13485, FDA 21 CFR Part 820, EU MDR, and other applicable regulatory standards.
Support internal and external audits by providing CAPA documentation and participating in audit activities.
Assist with training team members on CAPA processes and quality system requirements.
Contribute to ongoing continuous improvement efforts and quality system enhancements.
Perform other duties as assigned.