Quality Systems Specialist

VB Spine, LLC; Leesburg (VA); Hybrid; USD 75,000 - 85,000; Full time

Benefits offered by this job

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 the company

Job summary

VB Spine, LLC in Leesburg, VA is looking for a Quality Systems Specialist to develop and manage the Quality Management System (QMS) to ensure compliance with regulatory requirements. The role requires collaboration across teams while maintaining the highest standards for medical devices.

The ideal candidate has a Bachelor’s degree, thorough knowledge of medical device regulations, and strong analytical and communication skills. The position offers a competitive salary and benefits including health insurance and 401(k).

Qualifications

• Thorough knowledge and understanding of US and International Medical Device Regulations.
• Basic knowledge of Quality Systems elements like CAPA, Audits, etc.
• Demonstrated ability to work effectively in cross‑functional team environments.

Responsibilities

• Support the development, implementation, and maintenance of the Quality Management System.
• Identify improvement opportunities for the QMS.
• Conduct internal and external audits and prepare necessary documentation.

Skills

Interpersonal communication skills

Analytical skills

Problem-solving skills

Project management skills

Computer proficiency

Education

Bachelor’s degree in a science, engineering, business, or related discipline

Job description

Quality Systems Specialist

Location: Leesburg, VA (Preferred) or Allendale, NJ (Hybrid) (10% Travel Required)

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 the largest privately held spine company and among the largest family‑owned medical technology companies in the world, dedicated to innovation, surgeon partnerships, and improving patient outcomes in spine care. As a Quality Systems Specialist in our Quality Systems function within the Spine division, you’ll play a key role in developing, maintaining, and continuously improving the Quality Management System (QMS) to ensure compliance with global regulatory requirements and support high‑quality, safe medical devices.

What You’ll Do:

• Support the development, implementation, and maintenance of the Quality Management System in alignment with US and international medical device regulations (FDA, ISO, MDD/MDR, etc.)
• Contribute to the evolution of the QMS to meet current and future business needs while ensuring compliance and efficiency
• Participate in Management Review, Quality Planning, and other key QMS forums
• Identify improvement opportunities and drive initiatives to increase the effectiveness and efficiency of the QMS
• Support GMP and GDP practices within the Quality organization
• Develop and deliver QMS‑related training and ensure effective communication of quality system requirements
• Contribute to the creation and maintenance of policies, procedures, and work instructions
• Support internal and external audits, including preparation, response, and follow‑up activities
• Participate in QMS‑related IS discussions and support change control assessments for quality systems
• Serve as a Divisional Process Owner (if applicable), coordinating input, representing divisional needs, and ensuring effective implementation of global initiatives
• Collaborate cross‑functionally with Quality, Regulatory, IT, and other teams to maintain a compliant and effective QMS

What You Bring:

• Bachelor’s degree in a science, engineering, business, or related discipline
• Thorough knowledge and understanding of US and International Medical Device Regulations
• Basic knowledge of Quality Systems elements (CAPA, Audits, Management Review, Quality Planning, etc.)
• Strong interpersonal, written, and oral communication skills with the ability to influence and negotiate
• Solid analytical, problem‑solving, and project management skills
• Demonstrated ability to work effectively in cross‑functional team environments
• Computer literacy and proficiency with standard business applications
• Ability to travel 10‑15% as needed

Why VB Spine?

We believe in growing talent from within. At VB Spine, join a high‑performing team where you’ll play an important role in strengthening our Quality Management System and ensuring the highest standards of quality and compliance for innovative spinal products that improve patient lives.

Compensation:

Pay for this role is competitive and based on experience, qualifications, and performance. The typical pay range for this position is $75,000.00 - $85,000.00 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, skillset, 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
• Opportunity to grow within a fast‑paced, dynamic company