Senior Quality Systems Manager

About the role

Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day. At Boston Scientific, our work changes lives. As the Senior Quality Systems Manager, you will play a critical leadership role in ensuring the Maple Grove site remains inspection-ready while driving excellence across the Quality Management System (QMS).

Responsibilities

• Lead, develop and mentor the Maple Grove Quality Systems team, building a culture of accountability, collaboration and continuous improvement.
• Establish and sustain site quality systems that support inspection readiness and compliance with Boston Scientific requirements and applicable global medical device regulations.
• Partner with site, divisional and global stakeholders to align local quality system processes with enterprise standards while ensuring effective governance and execution.
• Provide leadership for Quality Management Reviews (QMRs), management controls, quality planning and CAPA Review Board activities.
• Drive quality system process improvements across CAPA, nonconforming events, audit readiness, document control, training, quality planning and related quality system processes.
• Analyze quality system metrics, audit outcomes, CAPA trends and other quality signals to identify systemic risks, improve performance and drive preventive actions.
• Lead planning and execution activities supporting FDA inspections, notified body audits, MDSAP audits, customer audits and internal quality audits.
• Partner with Regulatory Affairs, Supplier Quality, Manufacturing, Engineering and other cross-functional teams to ensure compliant implementation of new products, acquisitions and quality system initiatives.
• Lead quality projects of significant scope and complexity that support site readiness, compliance, operational excellence and business objectives.
• Develop department objectives, staffing strategies and resource plans that align with business priorities and organizational growth.
• Provide technical guidance and mentorship on quality systems, regulatory requirements and compliance strategies across the organization.
• Demonstrate a commitment to patient safety and product quality by ensuring compliance with applicable regulatory requirements, Boston Scientific's Quality System and established quality processes.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs or a related technical discipline.
• Minimum of 10 years' experience in quality systems, quality engineering, regulatory compliance or a related function within the medical device industry or another highly regulated environment.
• Demonstrated expertise in ISO 13485 and FDA medical device quality system requirements, including experience translating regulatory requirements into effective business processes and quality controls.
• Experience implementing, managing or significantly improving quality system processes, including CAPA, nonconformance management, internal audits, external audit readiness, management review, document control, quality planning or supplier quality.
• Experience supporting FDA inspections, notified body audits, MDSAP audits, customer audits or equivalent external regulatory inspections.
• Minimum of 2 years' experience leading people or cross-functional teams.