Description: 

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

Location: Warren, New Jersey - 3 days on site & 2 days remote

Salary Range: 100k-120k

Key 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.

• Carries out other QMS responsibilities as assigned by management.
  

Qualifications: 

• 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 (ComplianceWire preferred)

• Proficiency in QMS platforms (Ennov preferred)

• Proficiency with data analysis tools for quality metrics (e.g., Excel, PowerBI).

• Excellent written and verbal communication skills.

• Effective organization and planning skills
  

Behavioral skills: 

• Curiosity: Keep on exploring uncharted territories. Always ask “why?” and more importantly “why not?”,

• Courage: Take smart risks, mentor each other to always do better & be accountable for our choices, our opinions, and our actions,

• Collaboration: Teamwork and spirit. Support each other and be equally involved in the achievement of our common goals,

• Credibility: Be transparent, follow through and build trust. Educate ourselves about our unique technology.