Quality Systems Specialist

VB Spine, LLC; South Carolina; On-site; USD 75,000 - 85,000; Full time

Benefits offered by this job

Comprehensive health, dental, and view

401(k) with company match

Paid time off (PTO) and holidays

Ongoing training and professional dev

Job summary

VB Spine, LLC is seeking a Quality Management System professional to support development, implementation, and maintenance of the QMS in line with FDA, ISO, and other medical device regulations. You will help evolve the QMS to meet business needs, participate in QMS forums, and drive improvements across cross-functional teams.

The role emphasizes training, policy maintenance, audits support, and change control assessments to uphold quality and compliance for spinal products.

Qualifications

• Bachelor’s degree in a science, engineering, business, or related discipline.
• Thorough knowledge 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.

Responsibilities

• 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

Skills

Medical device regulations

Quality systems basics

Communication skills

Analytical/problem solving

Cross-functional teamwork

Project management

Computer literacy

Travel ability

Education

Bachelor's degree in science/engineering/business

Job description

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