Quality Assurance Officers

Red Duke Strategies (RDS) is seeking a Quality Specialist to support our contract work with X_Labs, a healthcare innovation office within the US Department of Veterans Affairs’ Veterans Health Administration that delivers new and emerging healthcare technologies for Veterans. This role provides critical quality system support for medical device development, manufacturing, and clinical translation activities conducted within X_Labs.

The Quality Specialist plays a key role in supporting compliance, operational excellence, and audit readiness at X_Labs. This position is responsible for tracking and ensuring the timely closure of audit findings and management review actions, maintaining and controlling all quality and regulatory documentation in accordance with Food and Drug Administration (FDA) medical device standards and internal quality system requirements, assessing electronic record compliance, and leading process improvements for sub-parts of the quality system.

The Quality Specialist will also support the development and delivery of training and contribute to continuous improvement initiatives. This role ensures that action items are resolved, documentation is consistently up-to-date and traceable, and quality standards are upheld across all X_Labs projects.

Success in this role requires diligent attention to detail, the ability to manage multiple quality and documentation workflows simultaneously, and effective collaboration with technical, clinical, and operational stakeholders. The position is full-time and onsite, with the work location split between the Beacon Hill VA Medical Center and the VA Fort Lawton Facility. Quality System Compliance

Monitor and interpret evolving regulatory standards, recommending and implementing updates to maintain ongoing compliance with FDA regulations and internal requirements.

Support audit readiness, and provide active assistance during internal audits, external inspections and regulatory assessments.

Oversee and facilitate the control, release, and storage of quality and regulatory documentation - including procedures, work instructions, templates, forms, etc. - Ensure documentation aligns with X_Labs quality system requirements and robustly supports product development, manufacturing, and clinical activities.

Change Management & Process Improvement

Administer standardized processes for document revisions and updates, ensuring that all changes are properly reviewed, approved, version controlled, communicated, and implemented across the organization, with clear documentation history and traceability.

Notify impacted teams of documentation changes and coordinate relevant training requirements to support effective implementation; ensure documentation of training completion is properly generated and stored.

Propose, develop, and collaborate on updates to controlled documents, driving process improvements aligned with the annual quality plan, regulatory changes, and operational needs.

perform gap analyses and provide work estimates and recommendations for transitioning to compliant electronic recordkeeping solutions.

Training & Cross-Functional Support

Provide training, guidance, and support to X_Labs staff regarding quality system requirements, documentation procedures, and best practices.

Serve as a resource for general quality support, fielding questions, assisting teams and fostering continuous quality improvement across projects.

Collaborate closely with engineering, clinical, research, and operational teams to gather input for process and document updates, and champion a culture of quality throughout the organization.

Manage multiple documentation and quality tasks and projects simultaneously, demonstrating strong organizational skills, attention to detail, and the ability to meet deadlines in a fast‑paced innovation environment.

Experience supporting documentation control within a regulated environment, preferably medical devices, healthcare, life sciences, or related technical fields.

Demonstrated experience with document control, controlled records, or quality-related action tracking.

Bachelor’s degree in engineering, life sciences, technical writing, or related field.

Familiarity with FDA medical device regulatory frameworks and quality management systems (ex. Experience supporting audits, change control processes, quality assurance activities, and multi-functional project teams.