Senior Quality Systems Engineer — QMS & CAPA Lead

Boston Scientific Corporation; Quincy (MA); Hybrid; USD 82,000 - 156,000; Full time

Job summary

Boston Scientific Corporation seeks a Quality Systems Engineer III in Massachusetts to lead and improve the Quality Management System. You’ll collaborate with cross‑functional teams to strengthen processes, mitigate risks, and ensure regulatory compliance across QA activities.

The role emphasizes technical leadership, CAPA management, and data‑driven quality improvements in a hybrid work model requiring 3 days on-site. No visa sponsorship is offered.

Qualifications

• Bachelor's degree with 5+ years' relevant experience or a Master's degree.
• Working knowledge of FDA QMSR and ISO 13485 requirements.
• Demonstrated technical writing skills for clear compliant documentation.
• Ability to analyze quality data, identify trends and determine corrective actions.

Responsibilities

• Lead and support QMS processes, including CAPA, nonconforming events, audits, and management review.
• Ensure compliance with regulatory requirements and standards (FDA QMSR, ISO 13485, ISO 14971).
• Provide guidance on investigations, root cause analysis, and effectiveness verification.
• Support audits and regulatory inspections, including site readiness and remediation activities.
• Analyze quality metrics to identify systemic risks and drive data‑driven improvements.
• Lead continuous improvement initiatives to enhance QMS effectiveness and efficiency.
• Collaborate with engineering, operations, and cross‑functional teams to resolve quality issues.
• Develop and maintain quality procedures and controlled documents.
• Apply risk‑based decision making to quality and compliance issues.

Education

Bachelor's degree

Master's degree

Job description

Boston Scientific Corporation seeks a Quality Systems Engineer III in Massachusetts to lead and improve the Quality Management System. You’ll collaborate with cross‑functional teams to strengthen processes, mitigate risks, and ensure regulatory compliance across QA activities.

The role emphasizes technical leadership, CAPA management, and data‑driven quality improvements in a hybrid work model requiring 3 days on-site. No visa sponsorship is offered.