QC Continuous Improvement CAPA Advisor

Location: Guaynabo, PR

The Q&C Continuous Improvement / CAPA Advisorfor Alivia Health’s Quality and Compliance Department is responsible for driving root-cause analysis and corrective action follow-through to improve processes and outcomes. Ensures a continuous improvement approach, identifying and developing action plans to reduce recurring events.

Responsibilities:

• Lead the development, implementation, documentation, and ongoing management of Corrective and Preventive Action (CAPA) Plans and Quality Improvement Plans (QIPs) resulting from monitoring activities, audits, investigations, compliance reviews, and identified risks.
• Partner with operational leaders, subject matter experts, and cross-functional stakeholders to conduct root cause analyses, develop sustainable corrective actions, and ensure effective remediation of identified issues.
• Ensure CAPA and QIP actions are clearly assigned, documented, executed, and completed within established timelines, including escalation of overdue actions and unresolved dependencies when necessary.
• Monitor and evaluate the progress and effectiveness of corrective actions, ensuring implementation evidence is complete and recommending additional actions when needed to achieve sustained compliance and performance improvement.
• Analyze monitoring, audit, investigation, and operational performance data to identify trends, recurring issues, and systemic opportunities for improvement.
• Collaborate with Operations and Operational Excellence (OpEx) teams to translate findings into process, policy, procedure, training, and organizational improvement initiatives, including projects with enterprise-wide impact.

Required:

• Bachelor's degree in Healthcare Administration, Nursing, Pharmacy, Public Health, Life Sciences, Industrial Engineering, Business Administration, Quality Management, or a related field from a four-year accredited college or university.
• 3-5 years of experience in healthcare quality, quality assurance, clinical operations, compliance, accreditation, risk management, patient safety, or a related healthcare function
• Experience facilitating Root Cause Analysis (RCA) methodologies and managing Corrective and Preventive Action plans.
• Experience in managing various internal clients’ requests across various business units.
• Excellent communication skills, both written and verbal (English/Spanish), with the ability to document effective corrective & preventive action plans.

• Ability to interpret guidelines and regulations to determine cases where non-compliance is exhibited and corrective actions are required.

***Equal Opportunity Employer M/F/V/D***