Quality Systems Manager

Quality Systems Manager

Boston Scientific is seeking a Quality Systems Manager to join the Global Quality Systems organization. In this leadership role, you will manage members of the Corporate Corrective and Preventive Action (CAPA) team while serving as the Quality Management approver for a portion of the Corporate CAPA portfolio. You will partner closely with the Senior Quality Systems Manager, CAPA Pillar Stewards (CAPA, NCEP and PIR), and cross-functional stakeholders to ensure the effectiveness, compliance and continuous improvement of Corporate CAPA, Nonconforming Event Process (NCEP) and Product Investigation Report (PIR) processes. This role offers the opportunity to influence global quality strategy, strengthen regulatory compliance and help foster a proactive quality culture across the organization.

This role follows a hybrid work model requiring employees to be in their assigned local office at least three days per week. This position may be based in our Arbor Lakes, Arden Hills or Maple Grove, Minnesota; Marlborough, Massachusetts; Spencer, Indiana; or other approved local Boston Scientific locations. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.

Your responsibilities will include:

• Lead, coach and develop members of the Corporate CAPA team.
• Serve as the Quality Management approver for a portion of the Corporate CAPA portfolio.
• Provide guidance to global eCAPA users regarding CAPA and NCEP management, issue resolution and escalation.
• Partner with CAPA Pillar Stewards and cross-functional stakeholders to ensure the effectiveness and continuous improvement of Corporate CAPA, NCEP and PIR processes.
• Support internal and external audits at the corporate and site levels, providing expertise on audit strategy, regulatory expectations and quality system compliance.
• Drive continuous improvement by implementing training, technical tools and process enhancements that strengthen a preventive quality culture.
• Ensure consistent implementation of CAPA, NCEP, PIR and other Global Quality functional excellence initiatives.
• Provide expert guidance on regulatory requirements, including FDA Quality Management System Regulation (QMSR), ISO 13485, EU MDR and other applicable regulations and standards.
• Lead and influence cross-functional initiatives that improve quality system effectiveness and operational excellence across the enterprise.

Required qualifications:

• Minimum Bachelor's degree in engineering, science or another related discipline.
• Minimum of 5 years' experience in Quality Systems.
• Minimum of 3 years' leadership experience, including direct or indirect people leadership.
• Demonstrated experience supporting, mentoring, reviewing or approving complex CAPAs.
• Proven knowledge of regulations and standards applicable to the Boston Scientific Global Quality System, including ISO 13485, FDA QMSR, 21 CFR Part 820, EU MDR and CAPA, NCEP and PIR processes.
• Demonstrated experience leading cross-functional initiatives and influencing stakeholders within a global matrix organization.
• Strong analytical, problem-solving and decision-making skills.
• Excellent verbal, written and presentation skills.

Preferred qualifications:

• Proven experience supporting internal audits, external audits or regulatory inspections.
• Proven experience managing multiple projects across diverse functional organizations.
• Demonstrated experience with enterprise quality systems, including eCAPA, Windchill and VIP.
• Advanced Microsoft Office Suite skills.
• Demonstrated ability to manage multiple high-priority deliverables in a fast-paced environment.
• Strong collaboration, negotiation and relationship-building skills.

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) 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.