CAPA & Quality Process Excellence Lead

Fresenius Medical Care; Waltham (MA); On-site; USD 140,000 - 200,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

Paid time off

Parental leave

Performance-based bonuses

Job summary

Fresenius Medical Care seeks a Sr. Manager, CAPA to lead the CAPA program across North America, aligning with FDA QMSR, ISO 13485, and global QMS standards.

You will drive governance, metrics, and corrective actions, collaborating with Engineering, Manufacturing, and Regulatory teams to deliver robust investigations and sustainable improvements. The role emphasizes cross-functional alignment, process simplification, and readiness for regulatory inspections, with a focus on quality excellence and

Qualifications

• 10+ years of CAPA, Quality, or Quality Systems experience in medical devices/related industries.
• Deep experience with QMSR processes, governance, and performance improvement.
• Proven ability to lead process transformation through influence across functions.

Responsibilities

• Lead CAPA program and process in line with regulatory requirements (FDA QMSR, ISO 13485).
• Provide regular CAPA performance updates to senior management.
• Ensure investigation, documentation, and closure of CAPAs and related events.

Skills

CAPA management

Regulatory compliance

Leadership

Cross-functional collab

Process improvement

Data-driven

QMSR knowledge

Regulatory inspections

Communication

Project management

Education

Bachelor's degree in Science/Engineering

Master's degree preferred

CQE/CQA certification

Tools

TrackWise

MasterControl

Veeva

Job description

Fresenius Medical Care seeks a Sr. Manager, CAPA to lead the CAPA program across North America, aligning with FDA QMSR, ISO 13485, and global QMS standards.

You will drive governance, metrics, and corrective actions, collaborating with Engineering, Manufacturing, and Regulatory teams to deliver robust investigations and sustainable improvements. The role emphasizes cross-functional alignment, process simplification, and readiness for regulatory inspections, with a focus on quality excellence and