Job Opportunities API

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 risk management activities, including developing risk plans/reports, conducting risk reviews, and verifying risk controls • 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 • Professional certifications (CQE, Six Sigma, Lead Auditor, etc.) highly desirable • 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 Senior 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 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.