Senior Quality Systems Engineer: QMS Lead & Compliance

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

Job summary

Boston Scientific in Maple Grove, MN is seeking a Senior Quality Systems Engineer to provide technical leadership for the Quality Management System (QMS) across CAPA, nonconformances, audits, and management reviews.

The role ensures compliance with FDA QMSR, ISO 13485, ISO 14971, EU MDR and partners with Engineering, R&D, Regulatory and Operations to resolve quality issues and drive improvements in a hybrid work model requiring in-office presence three days per week.

Qualifications

• Bachelor's degree in science or engineering required.
• 5+ years in medical device quality/regulatory environment.
• Strong knowledge of FDA QMSR, ISO 13485, ISO 14971, EU MDR.
• Proven experience in CAPA, audits, and risk management.

Responsibilities

• Lead and support QMS processes including CAPA, nonconforming events, internal and external audits.
• Mentor teams on investigations, root-cause analysis, corrective actions, effectiveness verification.
• Analyze quality metrics and drive data-based improvements.
• Lead continuous improvement initiatives to enhance QMS and compliance.
• Collaborate with Engineering, R&D, Regulatory, Operations to resolve quality issues and implement sustainable solutions.
• Prepare site for regulatory inspections and SME readiness, including finding responses and remediation.

Skills

CAPA

Internal audits

External audits

Management review

Quality metrics

Risk-based decisions

Cross-functional collaboration

Technical writing

Documentation

Project management

Mentoring

Team leadership

Education

Bachelor

Master

Tools

Quality Management Software

Regulatory databases

Job description

Boston Scientific in Maple Grove, MN is seeking a Senior Quality Systems Engineer to provide technical leadership for the Quality Management System (QMS) across CAPA, nonconformances, audits, and management reviews.

The role ensures compliance with FDA QMSR, ISO 13485, ISO 14971, EU MDR and partners with Engineering, R&D, Regulatory and Operations to resolve quality issues and drive improvements in a hybrid work model requiring in-office presence three days per week.