Overview
Fusion Search Engineer Jobs in Fairfax, VA at ECS Federal, LLC
Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one!
Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status.
Why you’ll love working at Axogen:
Friendly, open, and fun team culture that values unique perspectives
Company-wide dedication to profoundly impacting patients’ lives
Comprehensive, high-quality benefits package effective on date of hire
Educational assistance available for all employees
Matching 401(k) retirement plan
Paid holidays, including floating holidays, to be used at your discretion
Employee Stock Purchase Plan
Referral incentive program
Axogen Mission and Business Purpose
Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively target advancements in standards of care.
Job Summary of the Engineer I, Quality Systems
The Engineer I, Quality Systems is responsible for supporting the administration and continuous improvement of Quality Management System (QMS) processes across multiple functional areas. This role collaborates with Operations, IT, and other Axogen departments to ensure procedures, records, and systems are compliant with internal policies and external regulatory standards. This role reports to the Supervisor, Quality Systems, to support QMS-related activities across Axogen sites, ensuring that quality standards are upheld and that documentation and training systems are accurate, timely, and effective.
Requirements of the Engineer I, Quality Systems
Bachelor of Science Degree in Biomedical Engineering, Mechanical Engineering, Engineering Technology, or similar discipline required.
Minimum one year of experience in the pharmaceutical or medical device industry is preferred.
Experience with document and record control in regulated industries is preferred.
Strong judgment and creative problem-solving skills.
Excellent oral and written communication abilities.
Strong interpersonal skills and the ability to work well in team settings.
Highly organized, capable of managing multiple competing priorities efficiently.
Responsibilities of the Engineer I, Quality Systems
The specific duties of the Engineer I, Quality Systems include but are not limited to:
Write and revise procedures and controlled documents by collaborating with relevant stakeholders.
Support internal and external audits and inspections by preparing reports and documentation.
Ensure compliance with regulatory requirements and company procedures.
Execute the components of the quality management system and support relevant stakeholders through their execution.
Participate in risk assessments, investigations, and process improvements.
Maintain alignment with stakeholders to continuously improve the system.
Assist in the management and completion of quality records such as deviations, CAPAs, and change controls.
Participate in trending and reporting of Quality System metrics.
Document and Training Management.
Generate, issue, and reconcile executable documents in alignment with site operations, where applicable.
Act as a liaison between document authors and approvers to support efficient document workflow.
Maintain and improve the document control room, including physical and digital file management, where applicable.
Provide training support and act as system administrator within the electronic Quality Management System
Assign onboarding and role-based training for staff, ensuring proper documentation
Ensure timely and accurate filing, shipment, and archiving of documentation.
Computer System Validation (CSV):
Review validation deliverables (draft and executed) for compliance with internal procedures and regulatory standards.
Collaborate with system/process owners on validation and data integrity risk assessments.
Draft and review changes, deviations, periodic reviews, and quality records related to computerized systems.
Contribute to validation planning for new systems and processes.
Lead and/or assist with training related to CSV and Data Integrity practices.
Work closely with IT, QA, and cross-functional departments for alignment on system validation.
Support the organization with up to 25% travel for validation-related activities or audits.
Location
111 West Oak Ave., Tampa, FL 33602
#LI-AC1
Benefits/Compensation
Axogen follows healthcare system guidelines with respect to credentialing, vaccinations and other employment/compliance related requirements, as well as CDC guidance. Axogen reserves the right to amend its policies from time to time in its sole discretion.
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Title: Fusion Search Engineer
Company: ECS Federal, LLC
Location: Fairfax, VA
