Quality Systems Specialist

About the Job

We are seeking an experienced Quality Systems Specialist to support Quality Management System (QMS) activities within a regulated pharmaceutical, biotech, or medical device environment. This role will focus on maintaining compliance, supporting quality processes, and driving continuous improvement initiatives across the organization.

• Support and maintain QMS processes in compliance with cGMP, ICH Q10, FDA 21 CFR Parts 210/211, and EU GMP requirements
• Manage supplier quality activities, including supplier assessments, documentation reviews, and quality oversight
• Support internal and external audits, regulatory inspections, and inspection readiness initiatives
• Coordinate product complaint investigations, quality event management, and follow‑up activities
• Assist with quality metrics reporting, trend analysis, and continuous improvement programs
• Support CAPA, change control, deviation, and risk management processes as needed
• Collaborate with Quality Assurance, Manufacturing, Regulatory, and cross‑functional teams to ensure quality system effectiveness
• Maintain quality records, documentation, and compliance within eQMS platforms

• 5+ years of Quality Systems or Quality Assurance experience in Pharma, Biotech, Medical Device, or other regulated industries
• Strong knowledge of QMS requirements, GMP regulations, and quality compliance standards
• Experience with supplier quality, audits, product complaints, and inspection readiness activities
• Hands‑on experience using eQMS systems and Microsoft Office applications
• Strong communication, organizational, and problem‑solving skills