Sr. Quality System Engineer

Reva Medical LLC•San Diego, CA

7d•$80,000 - $110,000

About The Position

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.

Requirements

Strong knowledge of FDA 21 CFR 820, 210/211, Part 4 combination products, and ISO 13485 requirements.
Deep knowledge of quality assurance terminology, methods and tools
Excellent analytical, problem-solving and decision-making skills.
Demonstrated knowledge of quality best practices, version-control procedures and defect management processes.
Superb computer proficiency, including database management.
Bachelor's degree (or equivalent) in engineering or related field
Understanding of agile/scrum methodology and how QA functions within it.
Ability to communicate in more than one language

Responsibilities

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.
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.
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 workstreams 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.
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.
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 nonconformances and deviations.
Assist with coordination of assigned, limited-scope projects related to quality, manufacturing, or compliance.
Track action items, timelines, and deliverables for assigned initiatives.
Prepare status updates and communicate progress or risks to project owners or functional leads.
Support handoff and knowledge transfer activities as part of transition planning.
Coordinate with engineering, manufacturing, and supply chain teams to ensure quality requirements are followed.
Support quality-related activities for product development and manufacturing operations.
Provide routine status updates on assigned tasks and projects.
Collect and organize quality system metrics and project tracking data.
Maintain logs, trackers, and reports for audits, CAPAs, training, and assigned projects.