Hybrid Internal Quality Audit Lead

Boston Scientific; Maple Grove (MN); Hybrid; USD 78,000 - 149,000; Full time

Job summary

Boston Scientific is seeking a Quality System Engineer III to support internal audits and the broader quality management system at the Maple Grove site. The role emphasizes audit excellence, CAPA, and regulatory alignment with 21 CFR 820 and ISO 13485.

Hybrid work with a requirement to be in the office at least 3 days per week in Maple Grove, MN, and collaboration across multiple functions. Strong analytical skills and risk-based decision making are essential for success.

Qualifications

• Bachelor's degree required with 3+ years in quality/medical device or pharma.
• Auditing experience and familiarity with quality systems and standards.
• Strong written and verbal communication with detail orientation.

Responsibilities

• Execute and lead Internal Audits across the Maple Grove site.
• Document nonconformities, CAPA, and opportunities for improvement.
• Develop audit plans, schedules, and lead opening/closing meetings.
• Coordinate with cross-functional teams and report audit results.

Skills

Auditing

Quality engineering

Regulatory knowledge

Communication

Risk-based decisions

Education

Bachelor's degree

Job description

Boston Scientific is seeking a Quality System Engineer III to support internal audits and the broader quality management system at the Maple Grove site. The role emphasizes audit excellence, CAPA, and regulatory alignment with 21 CFR 820 and ISO 13485.

Hybrid work with a requirement to be in the office at least 3 days per week in Maple Grove, MN, and collaboration across multiple functions. Strong analytical skills and risk-based decision making are essential for success.