Senior CAPA & Quality Transformation Leader

Freseniusmedicalcare; Waltham (MA); On-site; USD 140,000 - 170,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) with company match

Paid time off

Job summary

Fresenius Medical Care is seeking a Sr. Manager, CAPA to drive end-to-end CAPA management across North America, aligning with FDA QMSR, ISO 13485 and global standards.

You will lead investigations, coordinate cross-functional teams, and implement robust corrective actions while improving how CAPA is managed locally and globally. The role requires deep regulatory knowledge, strong leadership, and a data-driven approach to identify systemic issues, develop improvements, and sustain CAPA

Qualifications

• Bachelor's degree in Science, Engineering, or related field
• Master's degree preferred
• CQE or CQA certification is a plus
• 10+ years of CAPA/Quality experience in medical devices
• Experience with ISO 13485, ISO 14971, 21 CFR QSR Part 820 and related standards

Responsibilities

• Lead CAPA program per 21 CFR 820 / FDA QMSR and global requirements
• Coordinate cross-functional teams for robust root-cause investigations
• Prepare CAPA documentation for regulatory review and inspections
• Drive CAPA improvements and governance across NA sites
• Mentor investigators and ensure high-quality CAPA records

Skills

CAPA experience

Quality Systems

Regulatory knowledge

Stakeholder influence

Data-driven improvement

Education

Bachelor's degree (Science/Engineering)

Master's degree preferred

CQE/CQA certification a plus

Tools

TrackWise

MasterControl

Veeva

Job description

Fresenius Medical Care is seeking a Sr. Manager, CAPA to drive end-to-end CAPA management across North America, aligning with FDA QMSR, ISO 13485 and global standards.

You will lead investigations, coordinate cross-functional teams, and implement robust corrective actions while improving how CAPA is managed locally and globally. The role requires deep regulatory knowledge, strong leadership, and a data-driven approach to identify systemic issues, develop improvements, and sustain CAPA