Sr. Quality Engineer

Senior Quality EngineerLocation: Leesburg, VACompany: 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 CQR function within the Spine division, you'll provide advanced quality assurance, control, and preventative expertise — supporting manufacturing processes, supplier quality, and compliance while driving continuous improvement across product and process quality.What You'll Do:Collaborate closely with Operations and cross-functional teams to ensure high quality performance of products and manufacturing processesServe as the Quality representative on cross-functional teams to resolve key quality issues in new product development and sustaining activitiesLead internal and supplier-driven non-conformances (NCs), CAPAs, and Material Review Board (MRB) dispositions with timely closureConduct risk management activities and support change management for internal and supplier processesPerform supplier control activities including on-site and desktop audits, maintaining the Approved Supplier List (ASL), and supporting part approval processesSupport and lead quality initiatives, internal/external audits, and inspection readiness activitiesReview, execute, and approve equipment, process, MSA, and software validation protocols and reportsMonitor quality KPIs, analyze trends, and drive corrective actions to improve process and product qualitySupport product transfers, engineering changes, manufacturing-related complaints, and field actionsApply statistical tools and process control methods to support quality system processes and management reviewsCollaborate with Regulatory on Instructions for Use (IFUs) and review/approve quality recordsMentor and train functional groups on GMP, quality concepts, and best practicesWork within the ERP system to support purchasing, manufacturing, and quality processesWhat You Bring:Bachelor's degree in Engineering required (Biomedical, Mechanical, Process, or related discipline preferred)Minimum 3+ years of experience in a quality engineering role within the medical device industry (or equivalent technical experience in a regulated manufacturing environment)Strong knowledge of Quality concepts (Risk Management, CAPA, Audits, Statistics) and regulatory requirements (ISO 13485, FDA QSR, EU MDR, etc.)Experience interacting with regulatory agencies and supporting audits (FDA, Notified Bodies, etc.)Proficiency in reading and interpreting engineering drawings and technical specificationsExcellent problem-solving, analytical, technical writing, and root cause investigation skillsStrong project management and cross-functional collaboration abilitiesProfessional certifications (CQE, Six Sigma, Lead Auditor, etc.) are highly desirableWhy VB Spine? We believe in growing talent from within. At VB Spine, join a high-performing team where you'll play a critical role in ensuring the quality and safety of innovative spinal implants and instruments 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 insurance401(k) with company matchPaid time off (PTO) and holidaysOngoing training and professional development opportunitiesOpportunity to grow within a fast-paced, dynamic company