Quality Systems Specialist
About The Position
VB Spine is seeking a Quality Systems Specialist to play an important role in strengthening their Quality Management System and ensuring the highest standards of quality and compliance for innovative spinal products that improve patient lives. This role involves supporting the development, implementation, and maintenance of the Quality Management System in alignment with US and international medical device regulations. The specialist will contribute to the evolution of the QMS to meet current and future business needs while ensuring compliance and efficiency. They will also participate in key QMS forums, identify improvement opportunities, and drive initiatives to enhance the QMS's effectiveness and efficiency. The position supports GMP and GDP practices, develops and delivers QMS-related training, and contributes to the creation and maintenance of policies and procedures. Additionally, the role involves supporting audits, participating in QMS-related IS discussions, and potentially serving as a Divisional Process Owner. Collaboration with cross-functional teams is essential for maintaining a compliant and effective QMS.
Requirements
- 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
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
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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
