Quality Assurance Specialist
About The Position
VB Spine is seeking a talented Quality Assurance Specialist to join their high-performing Quality team. This role will directly support product safety, compliance, and continuous improvement, contributing to the delivery of innovative spinal solutions that improve patient lives. The position involves developing and reviewing quality and operational documents, coordinating testing, managing purchasing controls, assisting in investigations, supporting audits, participating in change control, and collaborating with various departments throughout the product lifecycle. The specialist will also assist in continuous improvement initiatives, perform inspections, and support quality awareness tests.
Requirements
- Bachelor’s degree in a science or related discipline
- Minimum 2 years of experience in a manufacturing setting
- Strong knowledge of U.S. and international medical device regulations
- Basic knowledge of Quality Systems (CAPA, audits, Management Review, Quality Planning, etc.)
- Strong interpersonal, written, and oral communication skills with negotiation capability
- Analytical and problem-solving skills with demonstrated ability to work cross-functionally
- Ability to work independently, plan, and prioritize with minimal supervision
- Proficiency in Microsoft Office Suite, ERP systems, and Document Control software
- Strong decision-making, organizational, and detail-oriented skills
Nice To Haves
- Ability to read mechanical blueprints and familiarity with ANSI Y14.5 Geometric Tolerancing preferred
- Basic understanding of machining processes
Responsibilities
- Develop and review Quality and Operational documents, including SOPs, manufacturing records, test reports, and inspection records
- Coordinate routine microbiological testing (in-process and finished product) to verify compliance with specifications
- Coordinate and maintain purchasing controls and supplier quality agreements to support quality system compliance
- Assist in investigations for non-conforming products
- Support internal and external audits by providing documentation, responding to findings, and assisting with corrective actions
- Participate in change control activities and processes
- Collaborate closely with Production/Operations, QC, Regulatory Affairs, R&D, and Supply Chain to embed quality considerations throughout the product lifecycle
- Assist or lead continuous improvement initiatives in operations
- Perform inspections of incoming materials, in-process stages, and final products as needed
- Support Quality Awareness Tests and Process Improvement Reviews
- Interface with suppliers and support requests for internal and external manufacturing document management
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
- Potential for bonuses and incentives
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
