Quality System Specialist

Key Responsibilities

• eQMS Administration & Governance
• Serve as the eQMS System Administrator and Business Process Owner for quality system workflows.
• Configure, maintain, and optimize eQMS modules, workflows, forms, user roles, and permissions.
• Ensure system configuration aligns with approved SOPs, regulatory expectations, and data integrity principles.
• Act as primary liaison between Quality and IT for eQMS-related issues, enhancements, and upgrades.
• Support system access management, periodic access reviews, and audit readiness activities.
• Workflow Development & Validation
• Develop, configure, and maintain validated eQMS workflows, including: Complaints, CAPA, Change Control, Training, Document Control, Audits, Supplier Quality, Controlled Substances, Risk Management
• Author and execute system validation documentation (e.g., URS, FRS, IQ/OQ/PQ, validation summaries).
• Assess impact of system changes and support change control activities related to the eQMS.
• Ensure workflows support traceability, escalation, approvals, and regulatory reporting requirements.
• Reporting, Metrics & Dashboards
• Design, develop, and maintain QMS reports, KPIs, and dashboards to support:
• Management Review
• Quality performance monitoring
• Trending and risk identification
• Track and trend quality system metrics (e.g., CAPA aging, complaint trends, training compliance, audit findings).
• Analyze data to identify systemic issues and continuous improvement opportunities.
• Present quality system performance data to Quality leadership and cross-functional stakeholders.
• SME Support General Quality Systems
• Provide general quality systems SME support (e.g. Document Control, CAPA, Supplier Quality, Validation, Change Control, etc.).
• Ensure procedures and document workflows comply with document control SOPs and regulatory expectations.
• Support QMS training programs, including role-based training assignments and effectiveness tracking.
• Provide end-user support and troubleshooting related to eQMS workflows and reporting.
• Audit & Compliance Support
• Support internal, customer, and regulatory audits by providing eQMS records, reports, and system evidence.
• Ensure eQMS configuration supports compliance with applicable regulations and standards (e.g., FDA, ISO).
• Participate in inspection readiness activities related to electronic records and data integrity.
• Support continuous improvement of quality system processes and system usability.

Experience Required

• Minimum 4–6 years of experience in Quality Systems, Quality Assurance, or regulated systems administration.
• Hands-on experience administering and validating an eQMS in a regulated industry (medical device, pharmaceutical, or combination products).
• Experience developing workflows and reporting for multiple quality system processes.

Education

• Bachelor’s degree in science, engineering, information systems, or a related field.

Specialized Knowledge/Skills

• Strong understanding of regulated quality systems and electronic records requirements.
• Working knowledge of FDA regulations (e.g., 21 CFR 210, 211, 820, 803, 806, Part 11) and ISO standards (e.g., ISO 13485, ISO 14971).
• Experience with system validation and change control.
• Strong analytical, reporting, and data visualization skills.
• Excellent written and verbal communication skills.
• High attention to detail with strong organizational and planning skills.
• Ability to work cross-functionally and manage multiple priorities.

PC/Equipment

• Proficient in MS Office or the Google Platform
• Experience with eQMS platforms and reporting tools.

Work Environment/Physical Demands

• General office or remote work environment.
• Availability to support audits and system activities during U.S. business hours.
• Limited travel may be required.