Quality Systems SpecialistLocation: Leesburg, VA (Preferred) or Allendale, NJ (Hybrid) (10% Travel Required)Company: VB SpineLooking 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 efficiencyParticipate in Management Review, Quality Planning, and other key QMS forumsIdentify improvement opportunities and drive initiatives to increase the effectiveness and efficiency of the QMSSupport GMP and GDP practices within the Quality organizationDevelop and deliver QMS-related training and ensure effective communication of quality system requirementsContribute to the creation and maintenance of policies, procedures, and work instructionsSupport internal and external audits, including preparation, response, and follow-up activitiesParticipate in QMS-related IS discussions and support change control assessments for quality systemsServe as a Divisional Process Owner (if applicable), coordinating input, representing divisional needs, and ensuring effective implementation of global initiativesCollaborate cross-functionally with Quality, Regulatory, IT, and other teams to maintain a compliant and effective QMSWhat You Bring:Bachelor's degree in a science, engineering, business, or related disciplineThorough knowledge and understanding of US and International Medical Device RegulationsBasic 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 negotiateSolid analytical, problem-solving, and project management skillsDemonstrated ability to work effectively in cross-functional team environmentsComputer literacy and proficiency with standard business applicationsAbility to travel 10-15% as neededWhy 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 insurance401(k) with company matchPaid time off (PTO) and holidaysOngoing training and professional development opportunitiesOpportunity to grow within a fast-paced, dynamic company