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 in Massachusetts is seeking a Quality Systems Engineer III to lead QMS processes, CAPA and audits, aligning with FDA QMSR, ISO 13485 and ISO 14971. The role partners with engineering and operations to drive improvements and ensure compliant documentation.

The position follows a hybrid model, requiring presence in the local office at least three days per week; relocation and visa sponsorship are not offered.

Qualifications

• Bachelor's degree and at least 5 years' relevant experience, or master's degree.
• Working knowledge of FDA QMSR and ISO 13485 requirements.
• Demonstrated technical writing skills for compliant quality documentation.
• Experience analyzing quality data and identifying corrective actions.
• 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, audits, and management review.
• Ensure compliance with FDA QMSR, ISO 13485 and ISO 14971.
• Provide technical guidance and mentorship on investigations and root cause analysis.
• Support internal and external audits and regulatory inspections.
• Analyze quality metrics and trends to identify systemic risks and improvements.
• Lead continuous improvement initiatives to enhance QMS effectiveness and compliance.
• Collaborate with engineering and operations to resolve quality issues.
• Develop and maintain quality procedures and controlled documents.
• Apply risk-based decision-making to quality and compliance issues.
• Serve as a QMS SME and train cross-functional teams.
• Lead quality system projects and drive cross-functional execution.
• Partner with global teams to identify improvement opportunities.

Skills

Quality systems

Regulatory awareness

Data analysis

Technical writing

Education

Bachelor's degree or master's degree

Tools

FDA QMSR

ISO 13485

ISO 14971

Job description

Boston Scientific Corporation in Massachusetts is seeking a Quality Systems Engineer III to lead QMS processes, CAPA and audits, aligning with FDA QMSR, ISO 13485 and ISO 14971. The role partners with engineering and operations to drive improvements and ensure compliant documentation.

The position follows a hybrid model, requiring presence in the local office at least three days per week; relocation and visa sponsorship are not offered.