Quality Management Systems Engineer

Responsibilities

• Ensure QMS processes such as deviation, CAPA, change control, document control, and training are maintained in compliance with regulatory requirements and internal procedures, including management of associated electronic systems.
• Maintain and update QMS documentation, including SOPs, work instructions, and policies, ensuring they remain accurate, current, and compliant.
• Maintain control documents in eDMS, ensuring they follow the approved lifecycle and comply with established procedures.
• Serve as the business administrator for the eQMS, eDMS, and eLMS.
• Provide training and guidance to QMS end‑users.
• Act as a key liaison between the QMS team and other departments to ensure on‑time closure of QMS records.
• Participate in internal and external audits and support the preparation of regulatory inspection activities.
• Contribute to continuous improvement initiatives to optimize the efficiency and effectiveness of the QMS.
• Carry out other QMS responsibilities as assigned by management.

• Minimum of a BS, preferably in science or engineering.
• A quality assurance certification is preferred.
• Minimum 4 years of QMS activities in a bio/pharmaceutical, GxP‑related Quality & Compliance environment.
• Device and/or biologics experience is preferred.
• Experience in GxP documentation (policies, procedures, records, etc.) and training processes.
• Experience in maintaining QMS processes (electronic & manual).
• Knowledge of computerized systems validation/compliance.
• Proficiency with Veeva or similar electronic document management system.
• Working knowledge of learning management systems (Compliance Wire preferred).
• Proficiency in QMS platforms (Ennov preferred).
• Proficiency with data analysis tools for quality metrics (e.g., Excel, PowerBI).