Sr. Quality System Engineer

REVA is seeking a detail-oriented Quality Systems Engineer to support and maintain the company’s Quality Management System while also serving as the hands-on administrator of the current electronic Quality Management System (eQMS) and leading the selection and implementation of a new enterprise eQMS platform. This role blends day-to-day quality system execution — documentation, CAPA support, and audit readiness — with ownership of the technical administration and project management needed to keep the company’s digital quality infrastructure compliant, reliable, and positioned for growth.

This position is well suited for a professional who combines strong quality system execution skills with hands-on systems administration ability and the project management discipline to lead a multi-phase software selection and implementation effort from requirements through go-live.

Quality System Support

• Support the maintenance and execution of the ISO 13485/FDA Part 820 QSMR/Part 4 device-led combination product Quality Management System.
• Execute assigned quality system activities in accordance with established procedures.
• Assist in preparation for internal, external, customer, and supplier audits.
• Track audit findings and support closure of corrective actions as directed.

eQMS Administration

• Serve as the hands-on system administrator and business process owner for the company’s current electronic quality system based on Salesforce platform, including configuration, maintenance, and support of workflows, forms, records, permissions, dashboards, and related functionality for processes such as Nonconformance, CAPA, Change Control, training, document control, and complaints.
• Partner with internal stakeholders and external vendors to translate business and compliance needs into system requirements and configuration changes, including managing vendor support for changes beyond administrator-level permissions.
• Develop, revise, and maintain SOPs, work instructions, and training materials associated with electronic quality system processes.
• Coordinate and/or execute user acceptance testing, validation support activities, defect tracking, and implementation documentation in accordance with company procedures and regulatory expectations.
• Provide end-user support and training to improve adoption, data quality, and compliant use of electronic systems.
• Identify and recommend process and system improvement opportunities based on user feedback, audit observations, and operational needs.

eQMS Selection and Implementation

• Own day-to-day execution of the company’s eQMS selection and implementation initiative, from requirements gathering through solution evaluation, implementation planning, rollout, and post-go-live stabilization.
• Partner with Quality leadership to evaluate eQMS options, compare vendor capabilities, coordinate demonstrations, support business case development, and contribute to vendor selection and procurement decisions.
• Define and document user requirements, future-state process needs, functional gaps, implementation priorities, and risks for leadership review.
• Develop and maintain the project plan, timeline, decision log, action-item tracker, status reports, and risk/issue register for the eQMS program.
• Coordinate cross-functional project teams and work streams to align scope, resources, timelines, data migration needs, training plans, and change management activities.
• Communicate project status, key decisions, dependencies, and risks to stakeholders, including Quality leadership.
• Prepare agendas, facilitate working sessions, document outcomes, and drive completion of assigned deliverables.

Documentation & Change Control

• Maintain controlled documents, records, and training documentation within the QMS as part of QA team.
• Support document revisions, change requests, and record updates.
• Ensure documentation accuracy and compliance with quality system requirements.

CAPA & Nonconformance Support

• Support root cause analysis and corrective and preventive action (CAPA) activities.
• Track CAPA progress and verify completion and effectiveness under supervision.
• Assist with investigation and documentation of…