Senior CAPA & Quality Transformation Leader

CH01 CHE Fresenius Medical Care (Schweiz) AG; Waltham (MA); On-site; USD 140,000 - 180,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) with company match

Paid time off

Parental leave

Job summary

CH01 CHE Fresenius Medical Care (Schweiz) AG is seeking a Sr. Manager, CAPA to lead the CAPA program across North America sites, aligning with QMSR, ISO 13485, and FDA requirements.

You will drive investigations, corrective actions, and continuous improvement while partnering with Engineering, Manufacturing, R&D, Regulatory, and Supplier Quality. The role emphasizes simplification, global alignment, and strong governance to ensure compliant, effective CAPA solutions and timely inspections

Qualifications

• Bachelor’s degree in Science, Engineering or related field.
• Master’s degree preferred for senior CAPA leadership.

Responsibilities

• Leads CAPA program and process across NA sites per 21 CFR 820 and QMSR.
• Ensures proper investigation, documentation, and closure of CAPAs and nonconformances.
• Drives CAPA improvements and education across cross-functional teams.
• Supports regulatory inspections and audits; develops KPIs and dashboards.

Skills

CAPA expertise

QMSR & ISO 13485

Regulatory inspections

Data-driven improvement

Influence senior stakeholders

Leadership & mentoring

Process design & governance

Cross-functional collaboration

Executive presentation

Education

Bachelor’s degree

Master’s degree preferred

Tools

TrackWise

MasterControl

Veeva

Job description

CH01 CHE Fresenius Medical Care (Schweiz) AG is seeking a Sr. Manager, CAPA to lead the CAPA program across North America sites, aligning with QMSR, ISO 13485, and FDA requirements.

You will drive investigations, corrective actions, and continuous improvement while partnering with Engineering, Manufacturing, R&D, Regulatory, and Supplier Quality. The role emphasizes simplification, global alignment, and strong governance to ensure compliant, effective CAPA solutions and timely inspections