Senior Staff Quality System Specialist

Location: Leesburg, VA (preferred) or Allendale, NJ (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 seeking an experienced quality professional to lead the strategic development of our Quality Management System (QMS) in accordance with global medical device regulations. You will ensure our QMS is effective, efficient, and capable of supporting both regulatory clearance/certification and our innovation-driven growth.

What You’ll Do

• Ensure QMS compliance with applicable internal and external regulatory requirements, including FDA, ISO, MDD/MDR, US State, and international standards.
• Optimize QMS for both current operations and future business needs.
• Drive strategic improvements and integrate best-in-class practices into the QMS.
• Lead or participate in Management Review, Quality Planning Review, and related forums.
• Develop and modify QMS processes, policies, and procedures for efficiency and compliance.
• Oversee GMP and GDP compliance across the organization.
• Provide QMS training and mentor team members in compliance best practices.
• Liaise with Notified Bodies and Health Authorities to manage certification changes.
• Support New Product Development (NPD) and project milestone achievement through QMS activities.
• Perform gap assessments and implement improvement projects.
• Act as owner for assigned QMS business processes.
• Lead and/or support internal and external audits.
• Maintain and configure eQMS, Document Management, and/or PLM systems as required.
• Approve QMS and IS change control assessments.
  
  

What You Bring

• Bachelor’s degree in science, engineering, business, or related discipline.
• Minimum 7 years of experience in a manufacturing environment, preferably regulated medical devices.
• Thorough knowledge of U.S. and international medical device regulations.
• Strong knowledge of core QMS processes (NC/CAPA, audits, Management Review, Quality Planning, field actions, document/change management, etc.).
• Experience implementing regulatory changes into QMS processes.
• Proven ability to configure and utilize eQMS, Document Management, and/or PLM systems.
• Exceptional communication, project management, and influencing skills across all organizational levels.
• Ability to work independently, make effective decisions, and manage multiple concurrent tasks.
• Strong analytical and problem-solving skills, with a risk-based approach to continuous improvement.
• Collaborative, relationship-focused mindset with customer/stakeholder orientation.
• Willingness to travel 10–20% for business needs.
  
  

Why VB Spine?

We believe in growing talent from within. At VB Spine, you’ll join a high-performing team, benefit from mentorship at all levels, and help shape the future of spinal care through innovation and quality excellence. Your expertise will directly contribute to improving patient outcomes and advancing medical technology.

Compensation

$140,000 – $155,000 annually, plus potential bonuses and incentives. Final compensation is determined based on experience, qualifications, 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
• Opportunities to grow within a fast-paced, dynamic company