Sr. Quality Engineer

VB Spine, LLC; New Jersey; On-site; USD 95,000 - 110,000; Full time

Benefits offered by this job

Health, dental, and vision insurance

401(k) with company match

PTO & holidays

Training & development

Growth opportunities

Job summary

VB Spine in Leesburg, VA or Allendale, NJ is seeking a Senior Quality Engineer to provide advanced support in QA, control, and preventive activities. You will manage quality processes for internal and external suppliers related to process development, verification, validation, and product transfer while ensuring full regulatory compliance.

The role collaborates with Operations and cross-functional teams, leads CAPA and NCs, performs supplier audits and MRB decisions, and supports product

Qualifications

• Bachelor's degree in an engineering field
• Minimum 3 years in a quality role in medical device or regulated manufacturing
• Strong knowledge of CAPA, audits, statistics
• Regulatory knowledge with ISO 13485, FDA QSR, EU MDR desired

Responsibilities

• Collaborate with Operations and cross-functional teams to ensure quality performance of products and processes
• Lead internal and supplier-driven CAPA and non-conformance investigations
• Serve as Quality representative on cross-functional teams for key issues
• Manage supplier audits, MRB, ASL, and quality records
• Support product transfers, engineering changes, and field actions
• Review and approve validation protocols and reports
• Train groups on GMP and quality best practices

Skills

Quality concepts

CAPA

Audits

Statistics

Project management

Regulatory knowledge

Engineering drawings

Education

Engineering degree (Biomedical/Process/Mechanical)

Job description

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