Sr. Quality Engineer
About The Position
VB Spine is seeking a Sr. Quality Engineer to join their high-performing Quality team. This role is critical in ensuring the safety, compliance, and continuous improvement of innovative spinal products that improve patient lives. The position involves collaborating closely with Operations and cross-functional teams to ensure the quality performance of products and processes, serving as the Quality representative on these teams, and executing quality initiatives that support compliance and drive process improvements. The role also supports the development and maintenance of internal procedures, critically assesses change management activities, leads risk management and non-conformance projects, and acts as a subject matter expert for audits.
Requirements
- 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)
- Strong project management skills and the ability to influence without authority
Nice To Haves
- 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
Responsibilities
- 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
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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
