Sr. Validation Engineer

Senior Validation Engineer Location: Leesburg, VA, Allendale, NJ, or Remote (15% Travel Required) Company: VB Spine Looking for a career where your work truly matters? At VB Spine, you’ll be part of a mission-focused team that supports surgeons during life-changing spinal procedures. We’re the largest privately held spine company and among the largest family-owned medical technology companies in the world, dedicated to innovation, surgeon partnerships, and improving patient outcomes in spine care. As a Senior Validation Engineer in our Quality function within the Spine division, you’ll lead validation strategy, execution, and lifecycle management for equipment, processes, software, and manufacturing systems — ensuring compliance, driving risk-based decision making, and supporting high-quality product performance. What You’ll Do: Develop, review, execute, and maintain validation protocols, reports, and documentation for equipment, manufacturing processes, measurement systems (MSA), and software to support new product introductions, process improvements, and sustaining activities Conduct periodic reviews of validated systems, equipment, processes, and software to ensure ongoing compliance and alignment with regulatory requirements and internal procedures Serve as the subject matter expert for validation and inspection processes, ensuring compliant implementation across internal teams and external suppliers Apply statistical analysis and process control methods to support management reviews, CAPAs, and quality system processes Lead quality system projects of moderate scope and complexity Collaborate closely with Operations and other business functions to ensure quality performance of products and processes Support the creation and maintenance of inspection methods, sampling plans, and first article inspections Apply foundational knowledge of manufacturing processes (milling, turning, heat treatment, passivation/cleaning) and their impact on product quality Execute quality deliverables related to engineering changes, product transfers, and supplier-initiated changes Lead the development, maintenance, and continuous improvement of internal procedures, SOPs, and work instructions Lead internal and supplier-driven non-conformances and manage timely closure of NCs What You Bring: Bachelor’s degree required (Engineering discipline preferred) Minimum of 5 years of experience in a quality role within a medical device company (or equivalent technical experience in a regulated manufacturing environment) Strong knowledge of Quality concepts (Risk Management, CAPA, Audits, Statistics) Knowledge of applicable regulatory requirements (ISO 13485, FDA Quality System Regulation, EU MDR, etc.) required Experience interacting with regulatory agencies (FDA, MoH, TUV, etc.) preferred Professional certifications (CQE, CRE, Six Sigma, etc.) highly desirable Formal investigation, root cause analysis, and process improvement skills preferred Ability to read and interpret engineering drawings and technical specifications preferred Strong project management skills and the ability to influence without authority Excellent verbal, written, and interpersonal communication skills High attention to detail, strong analytical and technical writing skills, and the ability to multi-task independently Why VB Spine? We believe in growing talent from within. At VB Spine, join a high-performing Quality team where you’ll play a critical role in ensuring the validation integrity and compliance of systems that support the safety and performance of innovative spinal products. Compensation: Pay for this role is competitive and based on experience, qualifications, and performance. The typical pay range for this position is $105,000.00 - $135,000.00 annually, with potential for bonuses and incentives plus benefits. Final compensation is determined on a case-by-case basis and considers a variety of factors including experience level, technical expertise, and market conditions. Benefits include: Comprehensive health, dental, and vision insurance 401(k) with company match Paid time off (PTO) and holidays Ongoing training and professional development opportunities Opportunity to grow within a fast-paced, dynamic company