CAPA Program Lead – Medical Devices

Edwards Lifesciences; Salt Lake City (UT); On-site; USD 110,000 - 160,000; Full time

Job summary

Edwards Lifesciences in Salt Lake City seeks a CAPA Manager to lead the corrective and preventive action program in a regulated medical device environment.

You will own the CAPA process governance, drive investigations and root cause analysis, verify effectiveness, and partner with Quality, Regulatory Affairs, Manufacturing, and Engineering to prevent recurrence and improve patient outcomes.

This full-time role emphasizes leadership, mentorship, and continuous improvement across the site.

Qualifications

• Bachelor's degree with six (6) years of relevant experience or equivalent.
• Experience leading CAPAs within a regulated industry.
• Experience in regulated industries such as medical devices or pharmaceuticals.

Responsibilities

• Own and maintain CAPA governance framework and oversight of CAPA execution.
• Lead investigations, root-cause analysis, and corrective actions to prevent recurrence.
• Ensure compliance with FDA QSR/QMSR (21 CFR 820), ISO 13485, and EU MDR.
• Develop CAPA dashboards and monitor performance trends.
• Collaborate cross-functionally with Quality, Regulatory, Manufacturing, and Engineering.
• Coach and develop quality analysts and CAPA coordinators.

Skills

CAPA management

Regulatory compliance

Root cause analysis

Quality systems

Cross-functional leadership

Project management

Data analysis

Leadership coaching

Risk assessment

Continuous improvement

Education

Bachelor's degree

Engineering degree

Job description

Edwards Lifesciences in Salt Lake City seeks a CAPA Manager to lead the corrective and preventive action program in a regulated medical device environment.

You will own the CAPA process governance, drive investigations and root cause analysis, verify effectiveness, and partner with Quality, Regulatory Affairs, Manufacturing, and Engineering to prevent recurrence and improve patient outcomes.

This full-time role emphasizes leadership, mentorship, and continuous improvement across the site.