Quality Systems Leader: CAPA, QMR & Quality Planning

Boston Scientific; Maple Grove (MN); Hybrid; USD 102,000 - 194,000; Full time

Job summary

Boston Scientific is seeking a Quality Systems Manager to lead Management Control and CAPA across the Maple Grove site. You will partner with leadership to drive QMR/FSR improvements, oversee CAPA and NCEP activities, and ensure regulatory compliance across 21 CFR 820 and ISO 13485.

This hybrid role demands strong people leadership and cross-functional collaboration to advance a preventive quality culture. You will manage a team of quality professionals, align resources, and coordinate with

Qualifications

• Bachelor's degree
• Minimum of 5 years of relevant quality engineering experience in the medical device or pharmaceutical industry
• Experience with Corrective and Preventive Actions (NCEP, CAPA) and QMR processes
• Demonstrated leadership ability
• Conflict management and negotiation skills
• Solid project management skills
• Strong interpersonal skills with the ability to communicate and collaborate effectively with cross-functional stakeholders across various levels in the organization
• Knowledge of regulations/standards such as 21 CFR 820 and ISO 13485

Responsibilities

• Lead a team of employees to achieve organizational goals, mentor staff, and recruit a high-performing team.
• Promote continuous improvement aligned with Quality Policy, Core Values, and regulatory requirements.
• Determine staffing levels and schedules; coordinate with partners on priorities and resources.
• Serve as SME for QMR, FSR, and Quality Planning sub-processes; guide expectations and best practices.
• Improve QMR and FSR tools and governance with Site Leadership for visibility and robust actions.
• Guide CAPA mentors and manage resources in CAPA.
• Review and approve NCEP, CAPA, QMR, FSR, and Quality Planning docs.
• Develop and implement quality strategies and drive medium-scale projects.
• Drive standardization and best practices across sites; support audits and inspections.
• Be a Quality System resource for external audits and cross-functional mentoring.
• Maintain cross-functional relationships to support quality culture.

Skills

Leadership

CAPA/NCEP

QMR process

Project management

Cross-functional comms

Conflict management

Stakeholder engagement

Education

Bachelor's degree

Job description

Boston Scientific is seeking a Quality Systems Manager to lead Management Control and CAPA across the Maple Grove site. You will partner with leadership to drive QMR/FSR improvements, oversee CAPA and NCEP activities, and ensure regulatory compliance across 21 CFR 820 and ISO 13485.

This hybrid role demands strong people leadership and cross-functional collaboration to advance a preventive quality culture. You will manage a team of quality professionals, align resources, and coordinate with