Sr. Quality Engineer

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 risk management activities, including developing risk plans/reports, conducting risk reviews, and verifying risk controls
• 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
• Professional certifications (CQE, Six Sigma, Lead Auditor, etc.) highly desirable
• 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 $100,000.00 - $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