Senior Quality Engineer - Medical Devices CAPA & Compliance

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

Benefits offered by this job

Health insurance

401(k) with company match

Paid time off (PTO)

Job summary

VB Spine is seeking a Senior Quality Engineer to lead quality assurance, control, and preventative activities across internal and external suppliers related to process development, verification, validation, and product transfer. This role will ensure regulatory compliance and drive quality improvements.

The position requires collaboration with Operations and cross-functional teams, leading NCs/CAPAs, audits, and change management while supporting supplier control and KPI analysis.

Qualifications

• Bachelor’s degree in Engineering (Biomedical, Process, or Mechanical preferred).
• 3+ years in quality in medical devices or regulated manufacturing.
• Exposure to ISO 13485, FDA QSR, EU MDR desirable.

Responsibilities

• Collaborate with Operations and cross-functional teams to ensure product and process quality.
• Serve as Quality rep on cross-functional teams to address issues.
• Lead CAPA projects with root cause analysis and closure.
• Develop and maintain internal procedures, SOPs and work instructions.
• Manage supplier quality audits and MRB dispositions.
• Support product transfers and engineering changes with quality input.

Skills

Quality concepts

Risk management

CAPA

Audits

Statistics

Education

Bachelor’s degree in Engineering

Job description

VB Spine is seeking a Senior Quality Engineer to lead quality assurance, control, and preventative activities across internal and external suppliers related to process development, verification, validation, and product transfer. This role will ensure regulatory compliance and drive quality improvements.

The position requires collaboration with Operations and cross-functional teams, leading NCs/CAPAs, audits, and change management while supporting supplier control and KPI analysis.