Senior Quality EngineerLocation: Leesburg, VA or Allendale, NJ (25% Travel Required)Company: VB SpineLooking 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 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 processesServe as the Quality representative on cross-functional teams to address key quality issuesExecute quality initiatives that support compliance and drive process improvementsSupport the development, maintenance, and continuous improvement of internal procedures, SOPs, and work instructionsCritically assess internal and supplier change management activitiesLead risk management activities, including developing risk plans/reports, conducting risk reviews, and verifying risk controlsLead internal and supplier-driven non-conformances (NCs) and CAPA projects with timely root cause investigation and closureServe as a subject matter expert for internal and external audits, managing both front-room and back-room logisticsDisposition non-conforming product within the Material Review Board (MRB)Maintain and analyze quality KPIs to drive appropriate actionsPerform 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 suppliersSupport product transfers, engineering changes, manufacturing-related complaints, and field actionsReview, execute, and approve equipment, process, MSA, and software validation protocols and reportsCollaborate with Regulatory on Instructions for Use (IFUs) and review/approve quality recordsApply statistical analysis and process control methods to support quality system processesTrain functional groups on GMP and quality best practices as neededWhat 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.) desiredExperience interacting with regulatory agencies (FDA, MoH, TUV, etc.) preferredProfessional certifications (CQE, Six Sigma, Lead Auditor, etc.) highly desirableFormal investigation, root cause analysis, process improvement, and process-based auditing skills preferredAbility to read and interpret engineering drawings and technical specifications preferredStrong project management skills and the ability to influence without authorityWhy 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 $95,000.00 - $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 insurance401(k) with company matchPaid time off (PTO) and holidaysOngoing training and professional development opportunitiesOpportunity to grow within a fast-paced, dynamic company