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