Sr. Validation Engineer

About the role

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.

Location: Leesburg, VA, Allendale, NJ, or Remote (15% Travel Required)

Responsibilities

• 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

Requirements

• 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

Benefits

• 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

Pay

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.