Quality Assurance SpecialistLocation: Leesburg, VA (10% Travel Required)
Company: VB Spine
As a
Quality Assurance Specialist in our Operations Quality function within the Spine division, you'll play a key role in ensuring operational activities - including microbiological testing, inspections, manufacturing, and document review - meet established quality standards, regulatory requirements, and internal policies while driving continuous improvement.
What You'll Do:- 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
What You Bring:- 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
- Ability to read mechanical blueprints and familiarity with ANSI Y14.5 Geometric Tolerancing preferred
- Basic understanding of machining processes
- Proficiency in Microsoft Office Suite, ERP systems, and Document Control software
- Strong decision-making, organizational, and detail-oriented skills
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 - $90,000.00 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
