Senior Quality Systems Engineer

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

Job summary

Boston Scientific is seeking a Quality Systems Engineer III to provide technical leadership in the development, maintenance and continuous improvement of the Quality Management System (QMS). The role partners with cross-functional teams to strengthen quality processes, mitigate risks and drive improvements in regulatory compliance and operational efficiency.

The position follows a hybrid work model requiring in-office presence at least three days per week in the United States.

Qualifications

• Bachelor's degree and minimum 5 years' relevant experience.
• Working knowledge of FDA QMSR and ISO 13485 requirements.
• Demonstrated technical writing skills for compliant QC documentation.
• Experience applying risk-based approaches to quality decisions.
• Ability to work in the United States without current or future employer sponsorship.

Responsibilities

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

Skills

Technical writing

Quality data analysis

Risk-based decision-making

CAPA management

Root cause analysis

Cross-functional collaboration

Education

Bachelor's degree

Master's degree

Job description

Boston Scientific is seeking a Quality Systems Engineer III to provide technical leadership in the development, maintenance and continuous improvement of the Quality Management System (QMS). The role partners with cross-functional teams to strengthen quality processes, mitigate risks and drive improvements in regulatory compliance and operational efficiency.

The position follows a hybrid work model requiring in-office presence at least three days per week in the United States.