Senior Quality Systems Manager

Location: Maple Grove, Minnesota

As the Senior Quality Systems Manager, you will lead the Maple Grove site’s Quality Systems organization, partnering across functions to strengthen quality system performance, regulatory compliance, and operational effectiveness.

• Lead, develop and mentor the Quality Systems team, building a culture of accountability, collaboration, and continuous improvement.
• Establish and sustain site quality systems that support inspection readiness and comply 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 and ensure 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 processes.
• Analyze quality system metrics, audit outcomes, CAPA trends and other 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 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 aligned with business priorities and growth.
• Provide technical guidance and mentorship on quality systems, regulatory requirements and compliance strategies.
• Demonstrate commitment to patient safety and product quality by ensuring compliance with regulatory requirements, Boston Scientific’s Quality System and established processes.

• 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 related function within medical device industry or another highly regulated environment.
• Demonstrated expertise in ISO 13485 and FDA medical device quality system requirements, and experience translating regulatory requirements into effective business processes and quality controls.
• Experience implementing, managing or significantly improving quality system processes (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.