Senior Quality Systems Manager
About The Position
The Senior Quality Systems Manager is a highly visible, high-impact leader within the division and across the global Boston Scientific network. This role serves as a quality systems subject matter expert and business partner supporting cross functional collaboration. This role leads a team of quality professionals responsible for maintaining compliance with Boston Scientific Quality System requirements and applicable external regulatory requirements. The Senior Quality System Manager role provides strong leadership for key quality system processes, drives risk-based decision-making and continuous improvement, owns QMS performance, and ensures organizational readiness for regulatory inspections and external audits. The role will also serve as the Quality Manager responsible for the site metrology laboratory oversight, equipment control including document and records management for associated activities. This strong quality leader with proven experience promotes a culture of quality, prevention, and continuous improvement that supports adherence to the Boston Scientific Quality System, regulatory requirements, and the delivery of high-quality patient care. Boston Scientific was recognized by Forbes as one of the Best Workplaces for Engineers in 2026, reflecting a culture where engineers do meaningful work. Boston Scientific was also 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, we value collaboration and synergy. This role follows an onsite work model requiring employees to be in our local offices at least four (4) days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.
Requirements
- Bachelor’s degree in engineering, science, or a related technical discipline
- Minimum of seven (7) years of demonstrated quality management experience
- Minimum of three (3) years of direct people leadership experience
- Strong technical, analytical, and problem-solving skills
- Strong knowledge and application of Medical Device regulations, specifically ISO 13485 and FDA QMSR
- Ability to influence and collaborate effectively in a high-performing, matrixed global organization
- Leadership experience with FDA inspections and international regulatory or notified body audits
Nice To Haves
- Quality leadership experience within medical device, pharmaceutical, or similar highly-regulated industry
- Experience leading and executing internal and external audits and interacting with regulatory agencies
- Strong leadership in CAPA, document control, and Quality Management Review processes
- Demonstrated success driving continuous improvement and Quality System effectiveness
- Metrology experience
Responsibilities
- Lead, coach, and develop quality professionals; establish clear priorities, allocate resources, support individual development, and maintain a high-performing team
- Provide strong leadership for management of the division’s internal audit program, CAPA system, document control activities, and Quality Management Review process
- Analyze quality data for trends, emerging risks, recurring issues, and opportunities for improvement; drive actions resulting from management review through completion and effectiveness evaluation
- Translation of external regulatory requirements, standards, and emerging expectations into practical and sustainable quality system processes by working closely with the global quality organization
- Serve as Quality leader for management of divisional inspection readiness and lead execution of External Regulatory inspections and audit
- Serve as Quality Manager for the metrology laboratory day-to-day management in support of business objectives and quality objectives
- Apply professional expertise when making risk-based decisions to recommend compliant solutions, proactively resolve issues, and evaluate potential quality and business impacts
- Lead and deliver quality continuous improvement projects that support divisional and functional objectives and improve overall Quality System effectiveness and efficiency
- Build strategic partnerships across the division and global Boston Scientific network to provide strategic guidance to achieve organizational and Quality System goals
- Represent the division and quality function at site and cross-site meetings and global quality system communities of practice
- Keep Boston Scientific’s mission, values, and behaviors at the forefront of decisions and actions
- Champion a culture of prevention, compliance, and continuous improvement across the team, function, and site while demonstrating effective leadership through change
- Foster a diverse and inclusive workplace where all employees can contribute to their full potential in pursuit of organizational objectives
Benefits
- www.bscbenefitsconnect.com
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What This Job Offers
Job Type
Full-time
Career Level
Senior
