Quality Specialist, X_Labs

Quality Specialist, X_Labs 

About the Role 

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. 

Position Summary 

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.  It also demands proactive persistence and strong follow-up skills to ensure assigned actions and critical tasks are completed. 

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. Salary is competitive and commensurate with experience, up to $80,000.  

Key Responsibilities 

Quality System Compliance 

• Track, coordinate, and report on the follow-up and timely closure of internal audit findings and management review actions.  
• 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. 

Documentation & Records Management 

• Oversee and facilitate the control, release, and storage of quality and regulatory documentation – including procedures, work instructions, templates, forms, etc. – to ensure accuracy, traceability and compliance. 
• Ensure documentation aligns with X_Labs quality system requirements and robustly supports product development, manufacturing, and clinical activities.  
• Maintain a systematic filing and retrieval system, ensuring records are secure yet readily accessible to authorized personnel. 

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. 
• Assess electronic records and systems for FDA 21 CFR Part 11 compliance; 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. 

Workload & Time Management 

• 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. 

Required Qualifications 

• 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. 
• Strong organizational skills with exceptional attention to detail. 
• Ability to follow established processes while contributing to continuous improvement. 
• Clear written and verbal communication skills and the ability to work effectively with cross‑functional teams. 

Preferred Qualifications 

• Bachelor’s degree in engineering, life sciences, technical writing, or related field. 
• Familiarity with FDA medical device regulatory frameworks and quality management systems (ex. ISO  9001, ISO 13485, ISO 14971, 21CFR820, etc.) 
• Experience supporting audits, change control processes, quality assurance activities, and multi-functional project teams. 
• Prior experience working in or supporting government, federal healthcare, or VA environments. 
• Interest in long‑term career growth within public‑sector healthcare innovation roles. 

To Apply: Interested candidates should submit a resume and cover letter to hiring@reddukestrategies.com highlighting their qualifications and relevant experience aligned to the responsibilities listed above.