Manager, Quality Assurance

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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