About this opportunity
VB Spine, LLC lists this Sr. Quality Engineer opportunity in leesburg, Virginia. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Sr. Quality Engineer
VB Spine Leesburg, Virginia, United States
About this position
Sr. Quality Engineer
Location: Leesburg, VA or Allendale, NJ (25% 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 Sr. Quality Engineer in our Quality function within the Spine division, you’ll provide advanced support and direction in quality assurance, control, and preventative activities — managing quality processes for internal and external suppliers related to process development, verification, validation, and product transfer while ensuring full regulatory compliance.
What You’ll Do:
Collaborate closely with Operations and cross-functional teams to ensure quality performance of products and processes
Serve as the Quality representative on cross-functional teams to address key quality issues
Execute quality initiatives that support compliance and drive process improvements
Support the development, maintenance, and continuous improvement of internal procedures, SOPs, and work instructions
Critically assess internal and supplier change management activities
Lead internal and supplier-driven non-conformances (NCs) and CAPA projects with timely root cause investigation and closure
Serve as a subject matter expert for internal and external audits, managing both front-room and back-room logistics
Disposition non-conforming product within the Material Review Board (MRB)
Maintain and analyze quality KPIs to drive appropriate actions
Perform supplier control activities including audits, supplier file management, and maintenance of the Approved Supplier List (ASL)
Lead part approval activities and support process development/improvement efforts with suppliers
Support product transfers, engineering changes, manufacturing-related complaints, and field actions
Review, execute, and approve equipment, process, MSA, and software validation protocols and reports
Collaborate with Regulatory on Instructions for Use (IFUs) and review/approve quality records
Apply statistical analysis and process control methods to support quality system processes
Train functional groups on GMP and quality best practices as needed
What You Bring:
Bachelor’s degree required (Engineering discipline preferred — Biomedical, Process, or Mechanical Engineering recommended)
Minimum of 3 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 QSR, EU MDR, etc.) desired
Experience interacting with regulatory agencies (FDA, MoH, TUV, etc.) preferred
Formal investigation, root cause analysis, process improvement, and process-based auditing skills preferred
Ability to read and interpret engineering drawings and technical specifications preferred
Strong project management skills and the ability to influence without authority
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 safety, compliance, and continuous improvement of innovative spinal products that improve patient lives.
Compensation:
Pay for this role is competitive and based on experience, qualifications, and performance. The typical pay range for this position is $100,000.00 - $110,000.00 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, skillset, 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
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Worksite address
leesburg, VA, 22075, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.