Staff Design Quality Engineer

Staff Advanced Design Quality Engineer
Location
: Allendale, NJ or Leesburg, VA (hybrid)

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 looking for driven individuals ready to learn quickly, adapt under pressure, and grow in a dynamic, fast-paced environment. As a Staff Design Quality Engineer, you'll play a leading role in ensuring design excellence in new product development. This is a highly collaborative and technical position that drives quality throughout the product lifecycle—through design controls, risk management, verification and validation, and quality planning. Candidates may be located in Allendale, NJ or Leesburg, VA, with flexibility for hybrid work environment.

What You'll Do

• Act as the lead Quality Assurance representative on cross-functional new product development (NPD) teams
• Collaborate with technical experts in R&D, Process Development, Regulatory Affairs, Marketing, and Project Management to define design requirements and develop manufacturing processes for new product development
• Lead risk management activities and develop risk management plans and reports for product and process quality
• Create and maintain quality assurance documentation to support product development and regulatory submissions
• Identify and address gaps in design control processes and procedures
• Participate in design reviews to evaluate product risks and mitigation strategies
• Define and support design verification and validation test requirements and reports
• Promote efficient and statistically valid testing practices
• Support the definition of critical quality attributes and risk-based product evaluations
• Facilitate product design transfers to internal or external manufacturing
• Analyze feedback from early product launches and address quality issues
• Perform health risk assessments for post-market events
• Use tools such as FMEA, Root Cause Analysis, and GD&T for continuous improvement
• Interact with regulatory agencies and support audits and submissions

What You Bring- Bachelor's degree in science, engineering, or related discipline required
- MS, Certified Quality Engineer (CQE), or Certified Reliability Engineer (CRE) preferred
- Six Sigma Green or Black Belt preferred
- Minimum 5 years of experience in medical device or other regulated industries
- Knowledge of design and process verification and validation in product development
- Expertise with quality tools such as FMEA, GD&T, Root Cause Analysis, and Mistake Proofing
- Proficiency in reading and interpreting CAD drawings
- Experience with US and international medical device regulations and agency interactions (e.g., FDA, TUV, MoH)
- Strong foundation in quality concepts such as CAPA, audits, and statistics
- Ability to manage multiple projects in a matrixed organization
- Strong problem-solving, critical thinking, and communication skills
- Experience working in compliance and risk assessment scenarios
- Proficiency with Microsoft Office and statistical analysis tools (e.g., Minitab)