Quality Engineer

What You’ll Do:

• Serve as the Quality representative on cross-functional teams for new product development and changes to existing products or processes
• Execute quality initiatives to maintain compliance with standards and identify opportunities for process improvement
• Support the development, maintenance, and improvement of internal procedures, SOPs, and work instructions
• Participate in risk management activities, including risk plans, risk reviews, and verification of risk controls
• Contribute to design reviews by identifying risks and ensuring design and manufacturing documentation adequately mitigates them
• Support design verification and validation activities, including statistical analysis and clear reporting with graphical support
• Lead and manage non-conformances (NCs), CAPA projects, and Material Review Board (MRB) dispositions with timely closure
• Support internal and external audits (regulatory agencies, notified bodies) and ensure timely resolution of findings
• Perform supplier control activities, including audits, supplier file management, and monitoring
• Support product transfers between sites and execution of engineering changes, holds, complaints, and field actions
• Review and approve validation protocols/reports for equipment, processes, MSA, and software
• Collaborate with Regulatory Affairs on Instructions for Use (IFUs) and review/approve quality records
• Monitor quality KPIs, analyze trends, and drive appropriate corrective actions
• Apply statistical tools and process control methods to support quality system processes
• Advocate for Human Factors practices and support training initiatives as needed

What You Bring:

• Bachelor’s degree in Engineering required (Biomedical, Mechanical, Process, or related engineering discipline strongly preferred)
• Knowledge of core Quality concepts including Risk Management, CAPA, Audits, and Statistics
• Ability to read and interpret engineering drawings and technical specifications (preferred)
• Strong problem-solving, analytical, and technical writing skills
• Excellent verbal, written, and interpersonal communication skills
• High attention to detail with strong organizational and multi-tasking abilities
• Ability to work independently and effectively within cross-functional teams
• Willingness to travel up to 25% as needed

Why VB Spine?
We believe in growing talent from within. At VB Spine, join a high-performing team, benefit from peer and executive mentorship, and play a meaningful role in ensuring the quality and safety of innovative spinal devices 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 $80,000.00 - $95,000.00 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, engineering background, and market conditions in Leesburg, VA or Allendale, NJ.

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