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

Dental insurance

Vision insurance

401(k) match

PTO & holidays

Training & development

Growth opportunities

Job summary

VB Spine is seeking a Sr. Quality Engineer to join the Quality function in the Spine division.

You will provide advanced support and direction in quality assurance, control, and preventative activities, managing quality processes for internal and external suppliers related to process development, verification, validation, and product transfer while ensuring full regulatory compliance. You’ll lead risk management activities, CAPA projects, internal and supplier audits, and mentor teams on GMP and

Qualifications

• Bachelor's degree in Engineering or related field is required.
• Minimum 3 years quality experience in medical device or regulated manufacturing environment.

Responsibilities

• Collaborate with Operations and cross-functional teams to ensure product quality.
• Represent Quality on cross-functional teams to address key quality issues.
• Lead CAPA projects with root-cause investigation and closure.
• Dispostion non-conforming product in MRB and manage supplier quality.

Skills

Quality concepts

Risk management

CAPA

Audits

Statistics

Regulatory knowledge

Regulatory liaison

CQE

Six Sigma

Lead Auditor

Root cause analysis

Engineering drawings

Project management

Education

Bachelor's degree in Engineering

Job description

VB Spine is seeking a Sr. Quality Engineer to join the Quality function in the Spine division.

You will provide advanced support and direction in quality assurance, control, and preventative activities, managing quality processes for internal and external suppliers related to process development, verification, validation, and product transfer while ensuring full regulatory compliance. You’ll lead risk management activities, CAPA projects, internal and supplier audits, and mentor teams on GMP and