Manager, Quality Assurance

13 hours ago

Allendale, NJ, United States VB Spine LLC Full time
Manager, Quality Assurance

Location: Allendale, NJ preferred, or Leesburg, VA (Hybrid - 3 days onsite, ~20% travel)
Company: VB Spine

At VB Spine, we're committed to supporting surgeons with innovative spinal solutions that transform patient outcomes. We're seeking a Manager, Quality Assurance to lead quality functions across new product development and sustaining engineering. This role will establish a quality center of excellence, shape organizational strategy, and provide critical oversight to ensure regulatory compliance, risk management, and continuous improvement.

What You'll Do

  • Develop and execute quality strategies that align with product development, regulatory requirements, and business objectives.
  • Build, mentor, and lead a high-performing quality team, managing recruitment, onboarding, performance, and professional growth.
  • Act as Subject Matter Expert for quality systems, risk management, and design quality planning.
  • Lead hazard analyses, FMEA, benefit-risk assessments, and risk governance processes per ISO 14971.
  • Drive cross-functional collaboration with R&D, Manufacturing, Regulatory, and Service teams to ensure alignment of quality goals.
  • Oversee sustaining quality engineering projects, validations, product transfers, change controls, and calibrations.
  • Chair meetings to resolve quality issues, ensure accountability for CAPAs, and maintain audit readiness.
  • Monitor and analyze quality metrics, identifying trends and implementing proactive improvements.
  • Provide strategic input on evolving regulatory requirements (FDA, ISO, EU MDR, and international standards).
  • Manage departmental budgets, resources, and efficiency initiatives to support organizational growth.
  • Support business development through quality due diligence and integration activities.
What You Bring
  • Bachelor's degree in Engineering; Master's degree preferred.
  • 8+ years of experience in medical device quality, including direct management experience.
  • Strong knowledge of global regulatory requirements (ISO 13485, FDA QSR, EU MDR, and international standards).
  • Experience with complaint handling, adverse event reporting, CAPA, and corrective action processes.
  • Demonstrated leadership with proven ability to manage teams, set strategy, and deliver results.
  • Strong technical knowledge of medical devices and design controls.
  • Skilled in process improvement, trending/analysis reporting, and project management.
  • Excellent communication, collaboration, and team-building skills.
Why VB Spine?

At VB Spine, your work directly impacts surgeons and patients worldwide. You'll join a mission-driven team where innovation, growth, and quality excellence are at the core of everything we do. With opportunities for leadership development and cross-functional collaboration, this is a chance to help shape the future of spinal surgery.

Compensation

Pay for this role is competitive and based on experience, qualifications, and market factors.
Typical range: $155,000 - $175,000 annually, with potential for bonuses and incentives.

Benefits
  • Comprehensive health, dental, and vision insurance
  • 401(k) with company match
  • Paid time off (PTO) and holidays
  • Ongoing training and professional development
  • Career growth opportunities in a fast-paced, innovative company

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