Quality Systems Manager: CAPA & QMR Expert

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

Benefits offered by this job

Hybrid work model

Job summary

Boston Scientific seeks a Quality Systems Manager to lead a team in Maple Grove, driving CAPA, QMR, and quality planning programs. You will partner with cross-functional teams and site leadership to improve quality governance and regulatory readiness.

The role requires 5+ years in quality engineering within medical devices or pharma, plus strong leadership and regulatory knowledge. Hybrid work model with in-office requirement applies; relocation sponsorship is not offered.

Qualifications

• Bachelor's degree required.
• 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.
• Knowledge of regulations/standards such as 21 CFR 820 and ISO 13485.

Responsibilities

• Lead a team of employees in achieving organizational goals and recruit a high-performing staff.
• Promote continuous improvement aligning with Quality Policy and regulatory requirements.
• Determine staffing levels and schedules with partners to plan resources.
• Act as SME for QMR, FSR, and Quality Planning sub-processes and provide guidance.
• Maintain and improve QMR and FSR tools and governance models for visibility and robust actions.
• Partner with CAPA SME to manage CAPA mentors."
• Review and approve NCEP, CAPA, QMR, FSR, and Quality Planning documentation.
• Develop and implement quality strategies and drive quality projects of moderate scope.
• Drive standardization and adoption of best practices across sites.
• Support audits and inspections with documentation and SME guidance.
• Provide quality system expertise for external audit readiness across site functions.

Skills

People leadership

CAPA/NCEP

QMR

Quality planning

Management reviews

Cross-functional collaboration

Regulatory knowledge

21 CFR 820

ISO 13485

Education

Bachelor's degree

Job description

Boston Scientific seeks a Quality Systems Manager to lead a team in Maple Grove, driving CAPA, QMR, and quality planning programs. You will partner with cross-functional teams and site leadership to improve quality governance and regulatory readiness.

The role requires 5+ years in quality engineering within medical devices or pharma, plus strong leadership and regulatory knowledge. Hybrid work model with in-office requirement applies; relocation sponsorship is not offered.