Capa manager

Descripción del cargo

Responsibilities may include the following and other duties may be assigned:

Provides leadership and oversight for CAPA execution through assigned quality or CAPA support resources, ensuring adequate planning, resourcing, follow-through, and timely completion of corrective and preventive actions

Monitors CAPA, nonconformance, and quality data trends to identify systemic issues, support escalation decisions, and drive continuous improvement within the quality management system

Reviews and communicates CAPA-related trends, investigation outcomes, and associated quality signals to relevant stakeholders and cross-functional forums to support alignment, risk evaluation, and consistent execution of quality actions

Ensures CAPA-related documentation, investigations, and associated corrective actions meet applicable quality system requirements and are maintained in accordance with established procedures

Supports escalation and initiation of CAPA or CAPA requests when quality issues, nonconformances, or field-related concerns meet established criteria

Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to ensure compliance

Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations

Collaborates and leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits



Required Knowledge and Experience: 

Bachelor's degree

Minimum of 5 years relevant experience, or advanced degree with a minimum of 3 years prior relevant experience

Quality Systems and ISO 13485 & Medical Device Regulation knowledge

Fluent English level