Senior Quality Engineer – Medical Devices (25% Travel)

VB Spine, LLC; Leesburg (VA); On-site; USD 100,000 - 110,000; Full time

Benefits offered by this job

Health insurance

401(k) with company match

Paid time off

Professional development opportunities

Job summary

VB Spine, Leesburg, VA, seeks a Sr. Quality Engineer to lead quality assurance, CAPA, and supplier quality activities. Travel to Allendale, NJ 25% is required; collaborate across functions to ensure compliance with regulatory standards and sustain continuous improvement in quality systems.

The role emphasizes investigations, change control, and ensuring robust documentation while supporting product transfers and audits within a fast-paced medical device environment.

Qualifications

• Bachelor’s degree in engineering (Biomedical, Process, or Mechanical preferred).
• Minimum 3 years in quality within a medical device or regulated environment.
• Familiarity with ISO 13485, FDA QSR, EU MDR and related regulatory concepts.

Responsibilities

• Collaborate with Operations and cross‑functional teams to ensure product quality.
• Lead NCs and CAPA projects with root-cause analysis and closure.
• Maintain MRB, supplier quality activities, and audits.
• Review validation protocols and reports; support process transfers.
• Train groups on GMP and quality best practices as needed.

Skills

Quality Assurance

CAPA

Audits

Statistics

GMP

Education

Bachelor's degree in Engineering

Tools

Regulatory knowledge

Job description

VB Spine, Leesburg, VA, seeks a Sr. Quality Engineer to lead quality assurance, CAPA, and supplier quality activities. Travel to Allendale, NJ 25% is required; collaborate across functions to ensure compliance with regulatory standards and sustain continuous improvement in quality systems.

The role emphasizes investigations, change control, and ensuring robust documentation while supporting product transfers and audits within a fast-paced medical device environment.