Position Overview
We are seeking an experienced eQMS Configuration Specialist to support the implementation, configuration, optimization, and ongoing administration of electronic Quality Management Systems (eQMS).
This position is primarily remote, with periodic onsite work required in Dartmouth, Massachusetts.
The ideal candidate has hands-on eQMS configuration experience and a strong understanding of quality system processes within regulated environments. This individual will work directly with clients to understand business and quality requirements, translate those requirements into effective system configurations, troubleshoot issues, and identify opportunities to improve system performance and usability.
Position Responsibilities
- Configure and maintain eQMS functionality, with a primary focus on Document Control and Training modules.
- Support new system implementations, upgrades, enhancements, and configuration changes.
- Collaborate with clients to gather business requirements and translate them into effective system configurations.
- Conduct system and configuration assessments to identify opportunities for improvement, standardization, and optimization.
- Perform technical reviews of procedures and system processes to ensure alignment between documented requirements and system configuration.
- Configure workflows, metadata, user roles, permissions, and other system components based on approved requirements.
- Support client metadata entry, document preparation, and document migration/import activities.
- Create and manage user accounts, roles, and permissions to support client onboarding and ongoing system administration.
- Perform configuration testing and support verification activities prior to deployment.
- Troubleshoot system and configuration issues, perform root-cause analysis, and coordinate with technical support teams when escalation is required.
- Provide ongoing technical and configuration support to clients following implementation.
- Maintain accurate documentation of configuration decisions, system changes, requirements, and testing activities.
- Develop and maintain internal Standard Operating Procedures (SOPs), Work Instructions, Job Aids, and configuration documentation.
- Support continuous improvement initiatives related to eQMS configuration, administration, and client delivery.
- Participate in client meetings and provide configuration guidance, recommendations, and technical expertise.
- Perform additional duties and project activities as assigned.
Required Skills & Qualifications
- Experience configuring, implementing, or administering an electronic Quality Management System (eQMS).
- Hands-on experience with Document Control and Training modules.
- Understanding of document lifecycle management, training processes, workflows, metadata, user roles, and permissions.
- Ability to translate business and quality requirements into functional system configurations.
- Strong troubleshooting and analytical skills.
- Experience supporting system implementations, upgrades, enhancements, or configuration changes.
- Knowledge of controlled documentation, SOPs, Work Instructions, and quality system processes.
- Strong attention to detail and commitment to configuration accuracy and data integrity.
- Excellent written and verbal communication skills.
- Strong client-facing and communication skills.
- Ability to manage multiple projects, priorities, and client needs simultaneously.
- Ability to work independently in a remote environment while collaborating effectively with project teams, clients, and technical support resources.
- Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, and Teams.
Preferred Qualifications
- Experience working with eQMS platforms within the medical device, pharmaceutical, biotechnology, or other regulated industries.
- Familiarity with FDA-regulated quality systems and applicable GxP requirements.
- Experience with system validation, testing, or Computer Software Assurance (CSA) activities.
- Experience with data migration, document imports, metadata management, and system administration.
- Experience developing system documentation, configuration specifications, SOPs, Work Instructions, and Job Aids.
Work Environment
- Primarily remote position.
- Periodic onsite work in Dartmouth, Massachusetts is required.
- Client-facing role requiring effective communication, professionalism, and the ability to work collaboratively across multiple projects.
Pay: $55,000.00 - $75,000.00 per year
Work Location: Hybrid remote in Dartmouth, MA 02747
