Quality System Specialist

Quality Systems Specialist Our client is seeking a Quality Systems Specialist to support Quality Management System (QMS) processes, ensuring compliance with internal procedures and regulatory requirements.This is a 12-month contract with the possibility of extension.The role is primarily remote, but candidates in the Rockville, MD, or Princeton, NJ areas are preferred for one day per week on-site presence.Key Responsibilities:Review Quality Systems (QS) records in Trackwise to ensure completeness and compliance with internal procedures and applicable regulatory requirements.Monitor and track on-time closure of QS records, ensuring timely follow-up.Serve as the point of contact for QS record extension request justifications.Identify trends, emerging risks, and compliance gaps to elevate to management.Support root-cause analysis and provide investigation guidance.Collaboratively review and approve internal QS procedures.Serve as reviewer, approver, or owner of deviations, CAPAs, change control, or investigations.Review change control records for compliance, including impact analysis, risk assessment, and action item completion.Oversee QS performance monitoring using statistical methods and drive process improvements.Facilitate quarterly site metrics review meetings and assist in audits and inspections.Provide support and interface with vendors regarding investigations and root cause analysis reports.Qualifications & Experience:Bachelor's degree in science (engineering degree preferred).5+ years of experience in medical devices, combination products, device development, GMP manufacturing, or quality.Strong understanding of 21 CFR Part 820 and Part 4 requirements (preferred).Required Skills:Proficiency in electronic Quality Management Systems (Trackwise).Knowledge of cGMPGxP principles, Quality Management Systems, and global regulatory requirements.Experience using electronic document management systems, MS Office, and project management tools.

Created: 2025-02-21