Additional Location(s): US-MN-Maple Grove
About the role:
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). You will lead the site Quality Systems organization, partnering with Regulatory Affairs, Supplier Quality, Manufacturing, R&D and other cross-functional teams to strengthen quality system performance, regulatory compliance and operational effectiveness.
This role is ideal for a strategic leader who enjoys building high-performing teams, developing scalable quality systems and translating regulatory requirements into practical business processes that support innovation and patient safety.
Work model, sponsorship, relocation:
At Boston Scientific, we value collaboration and synergy. This position is based in Maple Grove, Minnesota, and follows a hybrid work model. Due to the leadership responsibilities of this role and the need for close partnership with cross-functional teams, the successful candidate is expected to work on-site three to four days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.
Your responsibilities will include:
• 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:
Required 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.
• Demonstrated experience using quality system metrics, audit outcomes and CAPA trends to identify risk, drive improvements and verify effectiveness.
• Minimum of 2 years' experience leading people or cross-functional teams.
Preferred qualifications:
• Advanced degree in Engineering, Life Sciences, Quality, Regulatory Affairs, Business or a related discipline.
• Experience establishing or transforming a quality management system, integrating acquisitions, transferring products or preparing a site for regulatory inspections or certification.
• Minimum of 5 years' experience leading quality, engineering, operations or regulatory teams.
• Experience leading Quality Management Reviews, management controls, CAPA Review Boards or enterprise audit programs.
• Experience performing portfolio-level analysis of quality system data across multiple products or manufacturing sites.
• Working knowledge of ISO 13485:2016, FDA 21 CFR Part 820/Quality Management System Regulation (QMSR), EU MDR, MDSAP and other applicable global medical device regulations.
• Familiarity with MWER, MREP, PRRC, Project Tracking Plans, Quality System Process Deviations and quarterly quality and compliance reporting.
• ASQ certification or equivalent professional certification, such as Certified Quality Engineer, Certified Quality Auditor, Certified Manager of Quality/Organizational Excellence or Six Sigma Green Belt/Black Belt.
• Demonstrated success building scalable quality systems, influencing senior leaders and driving continuous improvement within a matrixed organization.
Requisition ID: 631804
Minimum Salary: $ 125800
Maximum Salary: $ 239000
The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com-will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.
Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.
