CAPA Manager: Medical Device Quality & Compliance

Edwards Lifesciences; Draper (UT); Vor Ort; USD 110.000 - 170.000; Vollzeit

Zusammenfassung

Edwards Lifesciences is seeking a CAPA Manager to lead and continuously improve the Corrective and Preventive Action program in a regulated medical device environment. You will own governance, oversee CAPA execution, and drive timely resolution of quality issues with cross-functional partners.

This role emphasizes root cause analysis, verification of effectiveness, and development of dashboards to track performance, timeliness, and recurrence reduction across sites.

Qualifikationen

• 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.
• Experience working within highly regulated industries such as medical devices, pharmaceuticals, biotechnology, aerospace, automotive, semiconductor, or other regulated manufacturing environments.

Aufgaben

• 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.

Kenntnisse

CAPA leadership

Quality systems

Regulatory experience

Root cause analysis

Project management

Cross-functional collaboration

Ausbildung

Bachelor's degree in engineering or related field

Jobbeschreibung

Edwards Lifesciences is seeking a CAPA Manager to lead and continuously improve the Corrective and Preventive Action program in a regulated medical device environment. You will own governance, oversee CAPA execution, and drive timely resolution of quality issues with cross-functional partners.

This role emphasizes root cause analysis, verification of effectiveness, and development of dashboards to track performance, timeliness, and recurrence reduction across sites.