Global Quality Systems Lead — Medical Device

Select how often (in days) to receive an alert: Create Alert Diversity - Innovation - Caring - Global Collaboration - Winning Spirit- High Performance At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions. 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. 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. 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 Requisition ID:635085 Minimum 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 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. Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life byprovidinga broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological,neurologicaland urological diseases and conditions. Learn more at and follow us on LinkedIn . Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class. Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination. Among other requirements, Boston Scientific maintains specificprohibited substancetest requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law. Nearest Major Market: Los Angeles Job Segment: Pharmaceutical, Compliance, CAPA, Document Control, Quality Manager, Science, Legal, Management, Administrative, Quality #J-18808-Ljbffr Boston Scientific