Senior Quality System Manager

Additional Location(s):  N/A

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:

Boston Scientific was 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.

The Quality Systems Manager reports directly to the Director of Quality for the Quincy, Massachusetts, Distribution Center. This role provides leadership and oversight of the Quality Systems and Documentation Control/Services functions and is responsible for implementing and maintaining the Quality System across the North America region, including the Quincy and Mississauga, Canada, distribution sites.

This position ensures compliance with all Drug Wholesale activities affecting the Quincy distribution site to maintain licensure and certifications. The role partners with senior leadership and cross-functional stakeholders to drive regulatory compliance initiatives, continuous improvement efforts and strategic projects with significant corporate impact. The manager serves as a change leader, promoting a culture of quality, accountability and operational excellence.

Work model, sponsorship, relocation:

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three 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 and manage personnel, programs and initiatives related to the Quality System, CAPA, internal and external auditing, supplier auditing, documentation control and services, management review and Drug Wholesale licensure.

● Oversee all Quality Systems activities across the North America region, including Quincy and Mississauga, Canada, ensuring effective execution of internal and external audits, CAPA processes, management review and ongoing system maintenance.

● Establish and maintain Quality System policies and procedures in partnership with the Director of Quality Assurance, Corporate Quality Systems and Compliance groups, including systems impacting Quincy from other Boston Scientific facilities.

● Ensure substantial compliance with Quality System Regulation (QSR), ISO and applicable regulatory requirements, including Health Canada and Medical Device Directive standards.

● Partner with senior management to identify improvement opportunities, audit site-generated documentation, reconcile discrepancies and maintain compliance with external standards.

● Serve as an active member of the Boston Scientific Compliance Council and site leadership teams to drive continuous improvement initiatives.

● Provide strategic vision and leadership for high-impact projects and corporate initiatives.

● Collaborate across functions, regions and business units to implement strategies and tactical plans that deliver measurable results.

● Champion change in business practices and corporate culture to support operational excellence and regulatory compliance.

● Perform other duties and projects as required.

Quality system leadership expectations:

● Demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and documented quality processes.

● Ensure appropriate resources, including personnel and tools, are available to maintain Quality System compliance.

● Establish and promote a work environment that supports the Quality Policy and Quality System.

Qualifications:

Required qualifications:

● Bachelor’s degree in engineering, life sciences or a related discipline.

● Minimum of 7 years' experience in quality systems, quality assurance or regulatory compliance within a regulated industry.

● Minimum of 3 years' experience leading or managing professional teams.

● Comprehensive knowledge of GMP, Quality System Regulation (QSR), ISO and Health Canada requirements.

● Demonstrated experience managing audits, CAPA systems and regulatory inspections.

● Strong leadership, problem-solving and cross-functional collaboration skills.

Preferred qualifications:

● Experience within the medical device industry.

● Experience supporting distribution or supply chain operations.

● Experience leading Drug Wholesale licensure compliance activities.

● Advanced degree in a related field.

Requisition ID: 624763 

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 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.

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. 

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 specific prohibited substance test 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.