Senior Quality Systems Engineer - QMS Leader

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

Job summary

Boston Scientific is seeking a Senior Quality Systems Engineer to provide technical leadership for the QMS, ensuring regulatory compliance and continuous improvement. This hybrid role is based in Maple Grove, MN, and requires in-office presence several days per week.

You will guide CAPA, audits, risk-based decisions, and cross-functional collaboration with Engineering, R&D, Regulatory, and Operations to resolve quality issues and strengthen QMS effectiveness.

Qualifications

• Bachelor's degree or higher with 5+ years in medical device quality/regulatory.
• Strong understanding of FDA QMSR, ISO 13485, ISO 14971, EU MDR.
• Proven technical writing and documentation skills.
• Detail oriented with strong analytical abilities.
• Apply risk-based decision making for quality/compliance.

Responsibilities

• Lead and support QMS processes: CAPA, nonconformances, internal/external audits.
• Ensure regulatory compliance and lead investigations and effectiveness verification.
• Mentor teams on investigations, root cause, and corrective actions.
• Analyze quality metrics to drive data-based improvements.
• Partner with Engineering, Regulatory, Operations to resolve issues.

Skills

Technical writing

Attention to detail

Risk-based decision making

Quality systems knowledge

Education

Bachelor's degree in a medical device/quality/regulatory field

Master's degree in related field

Job description

Boston Scientific is seeking a Senior Quality Systems Engineer to provide technical leadership for the QMS, ensuring regulatory compliance and continuous improvement. This hybrid role is based in Maple Grove, MN, and requires in-office presence several days per week.

You will guide CAPA, audits, risk-based decisions, and cross-functional collaboration with Engineering, R&D, Regulatory, and Operations to resolve quality issues and strengthen QMS effectiveness.