Quality Systems Manager I — Internal Audit & CAPA (Hybrid)

Boston Scientific Gruppe; Arden Hills (MN); Hybrid; USD 102,000 - 194,000; Full time

Job summary

Boston Scientific is seeking a Quality Systems Manager I in Arden Hills, MN to lead a team responsible for Internal Audit and CAPA. This hybrid role requires on-site presence three days a week and collaboration with a global network to standardize and improve quality processes.

The candidate will mentor staff, drive continuous improvement, and ensure documentation and training compliance across the organization. Strong leadership and cross-functional partnering are essential.

Qualifications

• Bachelor's degree with 5+ years of related experience in medical device quality (or Master’s with 0-2 years).
• Experience with Corrective and Preventive Actions (NCEP, CAPA) and Internal Audit processes.
• Demonstrated leadership ability.
• Conflict management and negotiation skills.

Responsibilities

• Site ownership of Internal Audit and CAPA processes.
• Establish and promote continuous improvement in quality system compliance.
• Ensure training documentation and compliance across staff.
• Lead a high-performing team and recruit when needed.
• Foster diversity and inclusion within the workplace.
• Communicate quality performance to senior leadership and lead improvement meetings.
• Develop and implement quality strategies and drive projects of moderate scope.
• Review NCEP, CAPA and Internal Audit documentation for accuracy.
• Assist in department budgeting and resource planning.
• Maintain cross-functional relationships and policy compliance.

Skills

Leadership

Conflict management

Negotiation

Interpersonal skills

Education

Bachelor's degree with 5+ years

Master's degree with 0-2 years

Job description

Boston Scientific is seeking a Quality Systems Manager I in Arden Hills, MN to lead a team responsible for Internal Audit and CAPA. This hybrid role requires on-site presence three days a week and collaboration with a global network to standardize and improve quality processes.

The candidate will mentor staff, drive continuous improvement, and ensure documentation and training compliance across the organization. Strong leadership and cross-functional partnering are essential.