VB Spine · 11 hours ago
Staff Quality Engineer
Leesburg, VA
Full-time
Onsite
Senior Level, Lead/Staff
$105K/yr - $135K/yr
5+ years expVB Spine is a mission-driven organization developing and manufacturing innovative spinal technologies that improve patient outcomes. The Staff Quality Engineer will provide technical leadership and subject matter expertise across operations quality, supplier quality, and manufacturing processes, ensuring robust quality systems and regulatory compliance for both new and sustaining products.
E-CommerceHospitalManufacturingMedical Device
Hiring Manager
Matt Downey
Responsibilities
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 backroom 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
Qualification
Required
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
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
Ability to read and interpret engineering drawings and technical specifications
Strong project management skills with the ability to influence without direct authority
Excellent verbal, written, and technical communication skills
Highly organized, detail-oriented, and capable of managing multiple priorities independently
Preferred
Professional quality certification (e.g., CQE, CRE, Six Sigma, MS) strongly preferred
Experience with formal investigations, root cause analysis, and process improvement methodologies preferred
Benefits
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
Company
VB Spine
VB Spine provides spine implants and spinal solutions for surgical procedures and patient care.
1001-5000 employees
Funding
Current Stage
Late StageRecent News
2026-01-06
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