Sr. Quality Engineer

VB Spine; Leesburg (VA); On-site; USD 95,000 - 110,000; Full time

Benefits offered by this job

Health insurance

401(k) match

PTO & holidays

Professional development

Job summary

VB Spine in Leesburg, VA seeks a Senior Quality Engineer to lead quality assurance, control, and supplier quality for medical devices, covering process development, verification, validation, and product transfer in a regulated environment.

You will collaborate with Operations to ensure product quality, manage CAPA and NCs, support audits, and drive improvements, with 25% travel to Allendale, NJ. Requires a Bachelor's in Engineering and 3+ years of medical device quality experience.

Qualifications

• Bachelor’s degree in Engineering.
• Minimum 3 years of quality experience in medical devices or regulated manufacturing.
• Strong knowledge of quality concepts and statistics.
• Familiar with ISO 13485, FDA QSR, EU MDR (desired).
• Experience interacting with regulatory agencies preferred.

Responsibilities

• Collaborate with Operations 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 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 MRB.
• Maintain and analyze quality KPIs to drive appropriate actions.
• Perform supplier control activities including audits, supplier file management, and maintenance of the ASL.
• Lead part approval activities and support process development/improvement 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 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.

Education

Bachelor's degree in Engineering

Biomedical/Process/Mechanical Engineering preferred

Job description

Sr. Quality Engineer

VB Spine Leesburg, Virginia, United States

About this position

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.

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 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
• 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 $95,000.00 - $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