QA Specialist – Medical Devices & CI

VB Spine, LLC; Leesburg (VA); On-site; USD 75,000 - 90,000; Full time

Benefits offered by this job

Health, dental, and vision insurance

401(k) with company match

PTO and holidays

Ongoing training and professional dev

Job summary

VB Spine is seeking a Quality Assurance Specialist to join our Operations Quality team in Leesburg, VA. You will help ensure that microbiological testing, inspections, manufacturing, and document review meet quality standards and regulatory requirements while driving continuous improvement.

You will collaborate with Production, QC, Regulatory Affairs, R&D, and Supply Chain to embed quality considerations throughout the product lifecycle and support audits, investigations, and change controls.

Qualifications

• Bachelor's degree in science or related discipline is required.
• Minimum 2 years of experience in a manufacturing setting.
• Strong knowledge of U.S. and international medical device regulations.
• Familiarity with Quality Systems (CAPA, audits, Management Review, Quality Planning).
• Excellent interpersonal, written, and oral communication skills.

Responsibilities

• Develop and review Quality and Operational documents (SOPs, manufacturing records, test reports, inspection records).
• Coordinate microbiological testing to verify specification compliance.
• Maintain purchasing controls and supplier quality agreements to support quality system compliance.
• Assist investigations for non-conforming products and participate in change control activities.
• Support internal and external audits with documentation and corrective actions.
• Collaborate with Production/Operations, QC, Regulatory Affairs, R&D, and Supply Chain to embed quality across the product lifecycle.

Skills

Regulatory knowledge

Cross-functional collaboration

Analytical thinking

Independent work

Reading blueprints

Machining basics

Communication skills

Problem-solving

Microsoft Office

Education

Bachelor's degree in science

Tools

ERP systems

Document Control software

MS Office Suite

Job description

VB Spine is seeking a Quality Assurance Specialist to join our Operations Quality team in Leesburg, VA. You will help ensure that microbiological testing, inspections, manufacturing, and document review meet quality standards and regulatory requirements while driving continuous improvement.

You will collaborate with Production, QC, Regulatory Affairs, R&D, and Supply Chain to embed quality considerations throughout the product lifecycle and support audits, investigations, and change controls.