Job Description

• Bachelor's degree in Computer Science, Information Systems, Business, or a related field.
• Must Support quality remediation and compliance initiatives by managing nonconformance, CAPA, deviation, complaint handling, and quality system activities. Perform quality assessments, root cause investigations, data analysis, and quality improvement initiatives while ensuring compliance with medical device regulations and standards
• Must have a CAPA Lifecycle Management.
• You should have a Nonconformance and Deviation Management.
• Must have a Root Cause Analysis Techniques.
• Good Experience in 8+ years of Medical Device Quality Systems experience.
• You should have a Minimum 3 years of CAPA management experience.
• Strong Experience supporting regulatory audits and inspections.
• Good Experience in eQMS and Quality Metrics Reporting.
• Must have a FDA 21 CFR Part 820, ISO 13485, ISO 14971.
• Good Experience to Manage CAPA lifecycle from initiation to closure.
• Must Monitor CAPA timelines, aging, and effectiveness.
• You should Facilitate CAPA review meetings and follow-ups.
• Must Review CAPA documentation for compliance.
• Good Experience to Support audit and inspection readiness activities.

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