Sr. Quality Engineer

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

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.