Quality Engineer

Staff Quality Engineer

Location:

Leesburg, VA
Company: VB Spine

Looking for a career where your work truly matters? At VB Spine, you’ll be part of a mission‑driven organization developing and manufacturing innovative spinal technologies that improve patient outcomes. As a Staff Quality Engineer, you will serve as a senior individual contributor providing technical leadership and subject‑matter expertise across operations quality, supplier quality, and manufacturing processes. This role partners closely with Operations, Engineering, Regulatory, and Supply Chain to ensure robust quality systems and regulatory compliance for both new and sustaining products.

• Partner with Operations and cross‑functional teams to ensure quality performance of products and manufacturing processes
• Serve as the Quality representative on cross‑functional teams, addressing complex quality issues and driving resolution
• Lead quality initiatives supporting compliance with ISO 13485, FDA QSR, and global regulatory requirements
• Develop, maintain, and improve SOPs and work instructions in alignment with regulatory changes and business needs
• Critically assess internal and supplier change management activities, including engineering and supplier‑initiated changes
• Apply risk management principles to manufacturing operations and supplier processes
• Lead nonconformance investigations and manage timely closure of NCs
• Lead CAPA projects, including root cause analysis, implementation, effectiveness checks, and closure
• Serve as a subject matter expert during internal, supplier, and regulatory audits; lead audit back‑room logistics and support front‑room activities
• Maintain and analyze quality KPIs to identify trends and drive continuous improvement actions
• Participate in and lead Material Review Board (MRB) activities, including disposition of nonconforming product
• Lead supplier quality activities including audits, supplier qualification, supplier file maintenance, and ASL management
• Collaborate with suppliers and internal stakeholders on part approval, process development, and supplier certification initiatives
• Support and approve inspection methods, sampling plans, and validation activities
• Lead and support manufacturing process development and improvement initiatives
• Execute quality deliverables for engineering changes, product transfers, and supplier-driven changes
• Lead complex product transfers between sites, ensuring execution of all required quality activities
• Lead containment, communication, and investigation activities related to potential product escapes and field issues
• Support manufacturing‑related complaints, field actions, and corrective actions
• Review, execute, and approve validation protocols and reports (equipment, process, MSA, software)
• Collaborate with Regulatory Affairs on creation and revision of Instructions for Use (IFUs)
• Work within ERP systems to support purchasing, manufacturing, and quality processes
• Apply statistical analysis and process control methods to support CAPAs, management reviews, and quality system processes
• Advocate for human factors principles within manufacturing and process design
• Train and mentor junior quality team members and support onboarding and GMP training
• Provide leadership and technical expertise in Quality across the organization

• Bachelor’s degree required;
  Engineering degree preferred (Biomedical, Mechanical, or Process Engineering)
• Minimum of 5 years of experience in Quality or a technical role within a regulated medical device manufacturing environment
• Professional quality certification (e.g., CQE, CRE, Six Sigma, MS) strongly preferred
• Strong knowledge of quality system concepts including risk management, CAPA, audits, and statistical methods
• Working knowledge of ISO 13485, FDA QSR, and international medical device regulations
• Experience interacting with regulatory agencies, notified bodies, or competent authorities
• Experience with formal investigations, root cause analysis, and process improvement methodologies preferred
• Ability to read and interpret engineering drawings and technical specifications
• Strong project management skills with the ability to influence without direct…