Senior Quality Engineer - Medical Devices, CAPA Leader

Default Brand; Sterling (VA); On-site; USD 105,000 - 130,000; Full time

Job summary

Euclid Vision Corporation is seeking a Senior Quality Engineer to lead quality systems ensuring patient safety and product performance. You will own CAPA, perform root cause investigations, and drive quality improvements across development, validation, and manufacturing transfer.

The role partners with engineering, manufacturing, and leadership to meet ISO 13485, GMP, GDP, and 21 CFR 820 standards while advancing site KPIs and regulatory compliance.

Qualifications

• B.S. in Engineering with CQE certification preferred.
• 5–7 years of Quality Engineering experience in medical device industry.
• Hands-on CAPA, root-cause analysis and trending.
• Working knowledge of GMP, GDP, ISO 13485, and 21 CFR 820.

Responsibilities

• Lead and shape quality policies, procedures, and systems to meet standards.
• Drive CAPA, root cause investigations, and continuous improvement across teams.
• Own validation protocols for software, processes, equipment, and methods.
• Apply risk management and FMEA to strengthen operations.
• Mentor colleagues on quality processes and audit readiness.
• Represent Quality in audits and management reviews.

Skills

CAPA process

GMP/GDP/ISO13485

21 CFR 820

Analytical problem-solving

Education

B.S. in Engineering

CQE certification

Job description

Euclid Vision Corporation is seeking a Senior Quality Engineer to lead quality systems ensuring patient safety and product performance. You will own CAPA, perform root cause investigations, and drive quality improvements across development, validation, and manufacturing transfer.

The role partners with engineering, manufacturing, and leadership to meet ISO 13485, GMP, GDP, and 21 CFR 820 standards while advancing site KPIs and regulatory compliance.