Quality Engineer

Responsibilities:Develop, implement, and maintain quality systems and procedures in compliance with FDA, EMA, and cGMP regulations.Support deviation investigations, CAPAs, and change control activities.Review and approve manufacturing and quality documentation including SOPs, batch records, and protocols.Participate in internal audits, risk assessments, and inspection readiness effortsCollaborate with cross-functional teams (QA, QC, Manufacturing, Validation, Engineering) to ensure product quality and compliance.Lead continuous improvement initiatives for quality system enhancement.Requirements:8+ years of quality engineering experience in pharma or biotech.Strong understanding of FDA regulations, ICH Q8-Q10, and cGMP standards.Hands-on experience with CAPA, deviation management, and quality documentation.Excellent written and verbal communication skills.Strong problem-solving and analytical mindset.