Boston Scientific is seeking a Senior Quality System Manager to 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. The role is responsible for overseeing all Quality Systems activities across the North America region, ensuring effective execution of internal and external audits, CAPA processes, management review and ongoing system maintenance.
Requirements
- 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.
Benefits
- Competitive salary
- Benefits package
- Opportunity for advancement
- Collaborative work environment
- Access to training and development resources
