Hybrid Quality Systems Leader: CAPA & QMR

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

Job summary

Boston Scientific Gruppe in Maple Grove, MN, seeks a Quality Systems Manager to lead Management Control, CAPA, and QMR activities. You will supervise a team of quality professionals and partner with site leadership to drive compliance, effectiveness, and continuous improvement.

This hybrid role requires a proven quality leader with 5+ years in medical device or pharma, knowledge of 21 CFR 820 and ISO 13485, and strong collaboration across cross-functional teams. Relocation not offered.

Qualifications

• 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.
• 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 in the achievement of organizational goals; provide guidance to staff, assist them in attaining career goals, and recruit and maintain a high-performing team.
• Establish, support, and promote a work environment of continuous improvement that supports BSC’s Quality Policy, Core Values, Quality System requirements and appropriate regulations.
• Determine appropriate staff levels and schedules; work with key partners to understand priorities and plan resource allocation accordingly.
• Act as a Subject Matter Expert (SME) for Quality Management Review (QMR), Feeder System Review (FSR), and the Quality Planning sub-process, providing guidance on expectations, requirements, and best practices
• Partner with Site Leadership to maintain and improve QMR and FSR tools and governance models to provide appropriate visibility to signals and drive robust actions.
• Partner with the CAPA SME to provide guidance and manage resources of CAPA mentors
• Review and approve NCEP, CAPA, QMR, FSR, and Quality Planning documentation
• Develop and implement quality strategies; seek innovative approaches to attaining quality goals.
• Drive quality projects of moderate scope.
• Partner with cross-functional stakeholders to drive standardization and adoption of best practices across sites
• Drive continuous improvement and efficiencies to support a preventive quality culture
• Support internal and external audits and inspections by providing Management Control and Quality Planning related documentation and subject matter expertise
• Act as a Quality System resource for external audit readiness, providing guidance and mentoring across site functions regarding quality system compliance.
• Maintain and enhance cross-functional team relationships.

Skills

Quality leadership

Staff management

Cross-functional collaboration

Regulatory knowledge

Job description

Boston Scientific Gruppe in Maple Grove, MN, seeks a Quality Systems Manager to lead Management Control, CAPA, and QMR activities. You will supervise a team of quality professionals and partner with site leadership to drive compliance, effectiveness, and continuous improvement.

This hybrid role requires a proven quality leader with 5+ years in medical device or pharma, knowledge of 21 CFR 820 and ISO 13485, and strong collaboration across cross-functional teams. Relocation not offered.