Manager, Quality Assurance

Job Type: Location Type: Hybrid

 

Manager, Quality Assurance

Location: Allendale, NJ or Leesburg, VA (Hybrid – 3 days/week onsite, ~20% travel)
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 a Manager, Quality to lead and strengthen our design quality and risk management processes across the Spine division. This role is ideal for a quality leader with a strong background in design quality engineering and risk management, who thrives in guiding teams through complex problem-solving, compliance, and product development challenges.

What You’ll Do

• Promote and enhance VB Spine’s quality policy and quality system across the Spine division.
• Provide QA leadership and support throughout the product lifecycle, with a strong focus on new product development, risk management, and design quality engineering.
• Serve as an independent QA reviewer for design control deliverables, DHF/DMR files, custom dossiers, and management review sign-offs.
• Oversee divisional risk management, including defining requirements, establishing procedures, providing training, and ensuring compliance across sites.
• Support sustaining quality activities including validations, calibrations, product transfers, and change controls.
• Act as local QS compliance officer and conduct internal and vendor audits.
• Oversee microbiology and sterility assurance processes within the division.
• Supervise and coach a team of ~8 FTEs plus contractors, providing leadership, mentorship, and clear expectations.
• Provide QA support to prototype and custom shops, tissue bank operations, and divisional complaint handling.
• Continuously improve monitoring, reporting, and metrics for QA and compliance activities.

What You Bring

• Bachelor’s degree required.
• 2+ years of people management experience, with proven ability to lead, coach, and develop teams.
• Strong foundation in risk management, design controls, and design quality engineering.
• Experience in new product development within the medical device industry.
• Knowledge of regulations and standards applicable to spinal implants, instruments, and human tissue products (ISO 13485, 21 CFR 820, 21 CFR 1271, EU MDR, cGMPs).
• Familiarity with Japanese and Canadian regulatory requirements a plus.
• Strong communication skills with the ability to partner effectively across functions (engineering, regulatory, clinical, R&D, and operations).
• High attention to detail, problem-solving mindset, and ability to perform under competing priorities.
• Experience with PLM systems and advanced Microsoft Office/Adobe tools.

Why VB Spine?

We believe in growing talent from within. At VB Spine, you’ll join a high-performing team, benefit from mentorship, and play a pivotal role in ensuring product safety and compliance. You’ll have the opportunity to shape how quality supports innovation across our organization while building your career in a fast-paced, dynamic environment.

Compensation

Pay for this role is competitive and based on experience, with additional factors like qualifications and leadership scope taken into account.
Typical range: $155,000 – $175,000 annually, with potential for performance-based 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 opportunities
• Opportunity to grow within a fast-paced, dynamic company