Hybrid Senior Quality Systems Engineer, QMS & Regulatory

Boston Scientific Corporation; Maple Grove (MN); Hybrid; USD 85,000 - 162,000; Full time

Job summary

Boston Scientific Corporation is seeking a Senior Quality Systems Engineer in Maple Grove, MN for a hybrid role requiring 3 days in the office.

You will lead QMS processes, ensure regulatory compliance (FDA QMSR, ISO 13485, ISO 14971, EU MDR), and mentor teams through complex investigations and continuous improvement initiatives. Strong writing and risk-based decision skills are essential.

Qualifications

• Bachelor's degree with 5+ years of experience or Master's with 3+ years in medical device quality/regulatory environment
• Understanding of FDA QMSR, ISO 13485, ISO 14971 and EU MDR
• Strong technical writing and documentation skills
• Use a risk-based approach to quality and business decisions

Responsibilities

• Lead and support QMS processes including CAPA, nonconforming events, internal audits, external audits and management review.
• Ensure compliance with FDA QMSR, ISO 13485, ISO 14971, and EU MDR.
• Mentor teams leading complex investigations, root-cause analysis, corrective actions, and effectiveness verification.
• Support internal and external audits and regulatory inspections, including site preparation and SME readiness.
• Analyze quality metrics and trends to identify systemic risks and drive data-based improvements.
• Lead continuous improvement initiatives to enhance QMS effectiveness and operational efficiency.
• Partner cross-functionally with Engineering, R&D, Regulatory, Operations to resolve quality issues.
• Develop and maintain quality procedures, work instructions, and other controlled documentation.
• Apply risk-based decision-making to quality and compliance issues.
• Serve as a QMS subject matter expert, providing guidance and training to cross-functional teams.
• Lead quality-system projects and influence stakeholders for timely, compliant execution.
• Partner with Global teams to drive continual QMS improvements.

Skills

Attention to detail

Regulatory understanding

Technical writing

Risk-based decisions

Cross-functional teamwork

Education

Bachelor's degree

Master's degree

Job description

Boston Scientific Corporation is seeking a Senior Quality Systems Engineer in Maple Grove, MN for a hybrid role requiring 3 days in the office.

You will lead QMS processes, ensure regulatory compliance (FDA QMSR, ISO 13485, ISO 14971, EU MDR), and mentor teams through complex investigations and continuous improvement initiatives. Strong writing and risk-based decision skills are essential.