Senior Quality EngineerLocation: Leesburg, VA or Allendale, NJ (25% Travel Required)
Company: VB Spine
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 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
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
