Senior Quality System Manager

bostonscientific•Quincy, MA

1d•$131,700 - $250,200•Hybrid

About The Position

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.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.
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.