Quality Assurance Specialist

VB Spine
  • Leesburg, Virginia
    30+ days ago

    Job Description

    What You’ll Do:

    • Develop and review Quality and Operational documents, including SOPs, manufacturing records, test reports, and inspection records
    • Coordinate routine microbiological testing (in-process and finished product) to verify compliance with specifications
    • Coordinate and maintain purchasing controls and supplier quality agreements to support quality system compliance
    • Assist in investigations for non-conforming products
    • Support internal and external audits by providing documentation, responding to findings, and assisting with corrective actions
    • Participate in change control activities and processes
    • Collaborate closely with Production/Operations, QC, Regulatory Affairs, R&D, and Supply Chain to embed quality considerations throughout the product lifecycle
    • Assist or lead continuous improvement initiatives in operations
    • Perform inspections of incoming materials, in-process stages, and final products as needed
    • Support Quality Awareness Tests and Process Improvement Reviews
    • Interface with suppliers and support requests for internal and external manufacturing document management

    What You Bring:

    • Bachelor’s degree in a science or related discipline
    • Minimum 2 years of experience in a manufacturing setting
    • Strong knowledge of U.S. and international medical device regulations
    • Basic knowledge of Quality Systems (CAPA, audits, Management Review, Quality Planning, etc.)
    • Strong interpersonal, written, and oral communication skills with negotiation capability
    • Analytical and problem-solving skills with demonstrated ability to work cross-functionally
    • Ability to work independently, plan, and prioritize with minimal supervision
    • Ability to read mechanical blueprints and familiarity with ANSI Y14.5 Geometric Tolerancing preferred
    • Basic understanding of machining processes
    • Proficiency in Microsoft Office Suite, ERP systems, and Document Control software
    • Strong decision-making, organizational, and detail-oriented skills

    Why VB Spine?
    We believe in growing talent from within. At VB Spine, join a high-performing Quality team where your work will directly support product safety, compliance, and continuous improvement — helping deliver innovative spinal solutions 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 $75,000.00 - $90,000.00 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

    Numbers & Facts

    LocationLeesburg, Virginia

    Skills

    • American National Standards Institute (ANSI)unmatched
    • Analysis Skillsunmatched
    • Auditingunmatched
    • Blueprintsunmatched
    • Change Controlunmatched
    • Communication Skillsunmatched
    • Compensation Managementunmatched
    • Compensation and Benefitsunmatched
    • Continuous Improvementunmatched
    • Corrective Actionunmatched
    • Corrective and Preventative Action (CAPA) Systemsunmatched
    • Cross-Functionalunmatched
    • Document Controlunmatched
    • Document Managementunmatched
    • Documentationunmatched
    • ERP (Enterprise Resource Planning)unmatched
    • Establish Prioritiesunmatched
    • External Auditunmatched
    • Geometric Tolerancingunmatched
    • Internal Auditunmatched
    • Interpersonal Skillsunmatched
    • Machiningunmatched
    • Manufacturingunmatched
    • Manufacturing Managementunmatched
    • Medical Equipmentunmatched
    • Microbiologyunmatched
    • Microsoft Officeunmatched
    • Microsoft Visual Basicunmatched
    • Negotiation Skillsunmatched
    • Operational Auditunmatched
    • Operational Improvementunmatched
    • Patient Careunmatched
    • Presentation/Verbal Skillsunmatched
    • Problem Solving Skillsunmatched
    • Process Improvementunmatched
    • Procurement Managementunmatched
    • Product Lifecycleunmatched
    • Product Safetyunmatched
    • Product Supportunmatched
    • Quality Assuranceunmatched
    • Quality Assurance Methodologyunmatched
    • Quality Controlunmatched
    • Regulationsunmatched
    • Research & Development (R&D)unmatched
    • Safety Complianceunmatched
    • Standard Operating Procedures (SOP)unmatched
    • Supply Chainunmatched
    • Testingunmatched
    • Vendor/Supplier Relationsunmatched
    • Writing Skillsunmatched

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