CAPA Program Lead: Quality & Compliance

Edwards Lifesciences Gruppe; Draper (UT); On-site; USD 120,000 - 165,000; Full time

Job summary

Edwards Lifesciences is seeking a CAPA Manager to lead and continuously improve the Corrective and Preventive Action (CAPA) program within a regulated medical device environment. This role owns CAPA governance, drives investigations, and partners with cross-functional teams to prevent recurrence of nonconformances.

The successful candidate will ensure compliance with FDA QSR, ISO 13485, EU MDR, and MDSAP, develop dashboards, and coach quality professionals while advancing patient-focused quality

Qualifications

• Bachelor's degree with six (6) years of relevant experience; or equivalent work experience based on Edwards criteria.
• Proven experience leading, owning, and driving Corrective and Preventive Actions (CAPAs) within a regulated industry environment.

Responsibilities

• Own and maintain the CAPA process governance framework; establish governance, metrics, escalation pathways, performance standards, review boards, and prioritization based on risk, regulatory impact, patient safety, and business needs.
• Oversee Quality Systems CAPAs end-to-end from initiation through investigation, risk assessment, action planning, implementation, verification of effectiveness, disciplined tracking, and closure.
• Coach and lead teams in structured problem-solving and RCA tools; review investigations to ensure root causes are evidence-based, distinguished from symptoms, and addressed through systemic corrective actions.
• Ensure compliance with applicable FDA QSR/QMSR (21 CFR 820) requirements, ISO 13485, EU MDR, MDSAP expectations, global regulatory requirements, and internal quality procedures related to CAPA.
• Develop and maintain CAPA dashboards, analyze performance trends, communicate CAPA performance and escalation needs, and drive measurable improvements in timeliness, recurrence reduction, closure quality, and effectiveness verification.
• Partner with cross-functional stakeholders to build accountability, gain buy-in for systemic corrective actions, facilitate alignment, and drive prevention-focused quality improvements.
• Lead and develop quality analysts, quality engineers, or CAPA coordinators as applicable; provide coaching on quality systems, investigations, regulatory expectations, and talent development.
• Serves as the site-wide or large-scope CAPA owner, collaborating cross-functionally to facilitate alignment and drive actions that impact multiple teams.

Skills

CAPA leadership

Regulated industry experience

Quality systems knowledge

Root cause analysis

Project management

Education

Bachelor's degree + 6 years experience

Job description

Edwards Lifesciences is seeking a CAPA Manager to lead and continuously improve the Corrective and Preventive Action (CAPA) program within a regulated medical device environment. This role owns CAPA governance, drives investigations, and partners with cross-functional teams to prevent recurrence of nonconformances.

The successful candidate will ensure compliance with FDA QSR, ISO 13485, EU MDR, and MDSAP, develop dashboards, and coach quality professionals while advancing patient-focused quality