Additional Location(s): N/A
About the role: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.
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.
Your responsibilities will include:- 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
Required qualifications:- 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
Preferred qualifications:- 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
Requisition ID: 635085Minimum Salary: $ 131700 Maximum Salary: $ 250200 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).
