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CAPA & Quality Process Excellence Lead

Job in Waltham, Middlesex County, Massachusetts, 02254, USA
Listing for: Fresenius Medical Care
Full Time position
Listed on 2026-10-06
Job specializations:
  • Healthcare
  • Quality Assurance - QA/QC
Salary/Wage Range or Industry Benchmark: 140000 - 200000 USD Yearly USD 140000.00 200000.00 YEAR
Job Description & How to Apply Below

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

The CAPA & Quality Process Excellence Lead position in the Bio & Pharmacology & Health, Management & Operations field is open for applications.

The following opportunity is for a CAPA & Quality Process Excellence Lead with Fresenius Medical Care.

Our organisation is growing, and we are hiring a CAPA & Quality Process Excellence Lead in Waltham, MA, United States.

This opportunity is for the CAPA & Quality Process Excellence Lead role at Fresenius Medical Care.

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