Senior Quality Engineer – Medical Devices (CAPA/Audits)

VB Spine, LLC; New Jersey; On-site; USD 95,000 - 110,000; Full time

Benefits offered by this job

Health, dental, and vision insurance

401(k) with company match

PTO & holidays

Training & development

Growth opportunities

Job summary

VB Spine in Leesburg, VA or Allendale, NJ is seeking a Senior Quality Engineer to provide advanced support in QA, control, and preventive activities. You will manage quality processes for internal and external suppliers related to process development, verification, validation, and product transfer while ensuring full regulatory compliance.

The role collaborates with Operations and cross-functional teams, leads CAPA and NCs, performs supplier audits and MRB decisions, and supports product

Qualifications

• Bachelor's degree in an engineering field
• Minimum 3 years in a quality role in medical device or regulated manufacturing
• Strong knowledge of CAPA, audits, statistics
• Regulatory knowledge with ISO 13485, FDA QSR, EU MDR desired

Responsibilities

• Collaborate with Operations and cross-functional teams to ensure quality performance of products and processes
• Lead internal and supplier-driven CAPA and non-conformance investigations
• Serve as Quality representative on cross-functional teams for key issues
• Manage supplier audits, MRB, ASL, and quality records
• Support product transfers, engineering changes, and field actions
• Review and approve validation protocols and reports
• Train groups on GMP and quality best practices

Skills

Quality concepts

CAPA

Audits

Statistics

Project management

Regulatory knowledge

Engineering drawings

Education

Engineering degree (Biomedical/Process/Mechanical)

Job description

VB Spine in Leesburg, VA or Allendale, NJ is seeking a Senior Quality Engineer to provide advanced support in QA, control, and preventive activities. You will manage quality processes for internal and external suppliers related to process development, verification, validation, and product transfer while ensuring full regulatory compliance.

The role collaborates with Operations and cross-functional teams, leads CAPA and NCs, performs supplier audits and MRB decisions, and supports product