Quality Management Systems Engineer

The Quality Management Systems (QMS) Engineer is responsible for maintaining and supporting quality management systems and ensuring compliance with regulatory requirements. The role analyzes QMS data, supports audits and inspections, and collaborates with cross-functional teams to drive continuous improvement and enhance overall process effectiveness.

Location: Warren, New Jersey (minimum 3 days/week on site)
Salary Range: 100k–120k

Key Responsibilities
- Ensure QMS processes (deviation, CAPA, change control, document control, and training) are maintained in compliance with regulatory requirements and internal procedures, including electronic systems management.
- Maintain and update QMS documentation (SOPs, work instructions, policies).
- Maintain control documents in eDMS and manage lifecycle compliance.
- Serve as business administrator for eQMS, eDMS, and eLMS.
- Provide training and guidance to QMS end-users.
- Liaison between QMS and other departments to ensure on-time closure of QMS records.
- Participate in internal/external audits and support regulatory inspection activities.
- Contribute to continuous improvement initiatives; perform other QMS responsibilities as assigned.

Qualifications
- BS minimum (preferably science/engineering).
- Quality assurance certification preferred.
- 4+ years QMS activities in bio/pharma GxP Quality & Compliance (device and/or biologics experience preferred).
- Experience with GxP documentation and training processes.
- Experience maintaining QMS processes (electronic & manual).
- Knowledge of computerized systems validation/compliance.
- Proficiency with Veeva (or similar eDMS).
- Working knowledge of learning management systems (ComplianceWire preferred).
- Proficiency in QMS platforms (Ennov preferred).
- Data analysis tools for quality metrics (e.g., Excel, PowerBI).
- Excellent written/verbal communication; strong organization and planning.