QA Engineer

• Serve as the primary system administrator for the eQMS, managing user roles, permissions, workflows, and system access.
• Manage controlled documents (SOPs, policies, specifications) within the eQMS and oversee document creation, review, approval, version control, and archiving.
• Facilitates and organizes training matrix as well as training documents for employees on SOPs, documents, forms and GMPs and ensure company-wide compliance training is up to date.
• Oversee product complaints, including Adverse Event (AE) tracking, investigation, and reporting.
• Log and track non-conformances, deviations, and CAPA activities; monitor progress to ensure timely completion and effectiveness checks, analyze trends, and escalate recurring issues as necessary.
• Conduct internal audits and support third-party, FDA, and regulatory inspections.
• Generate and analyze quality KPIs and trends and present quality data for management reviews and continuous improvement initiatives.
• Collaborate with R&D, Product Development, Marketing, Legal, and Operations to support product innovation and go-to-market strategies.
• Advise executive leadership on quality and regulatory risks and opportunities.

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