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 cGMP/GxP principles, Quality Management Systems, and global regulatory requirements.
• Experience using electronic document management systems, MS Office, and project management tools.