Senior Quality Engineer - Elevate Patient Safety & Systems

Euclid Vision Corporation; Sterling (VA); On-site; USD 105,000 - 145,000; Full time

Job summary

Euclid Vision Corporation is seeking a Senior Quality Engineer to design, implement, and lead quality systems ensuring patient safety and product performance. You will act as SME for internal and third-party audits and support regulatory readiness across ISO 13485, GMP, GDP, and 21 CFR 820.

Reporting to the Director of Quality Assurance, you will drive CAPA, validation, and risk management while partnering with cross-functional teams to improve processes and product quality.

Qualifications

• B.S. in Engineering (or equivalent).
• CQE certification preferred.
• 5–7 years of Quality Engineering experience in medical devices is typical.

Responsibilities

• Lead quality policies, procedures, and systems to meet ISO 13485, GMP, GDP, and 21 CFR 820.
• Drive root cause analysis, CAPA, and continuous improvement with cross-functional teams.
• Own validation protocols for software, equipment, processes, and test methods.
• Apply statistical analysis, risk management, and FMEA to strengthen operations.
• Partner with QA leadership to hit site KPIs and drive portfolio quality improvements.
• Support new product development and manufacturing transfers with a quality-first lens.
• Train and mentor colleagues on quality processes and audits.

Skills

CAPA process

GMP/ISO13485 knowledge

Analytical skills

Cross-functional communicator

Education

B.S. in Engineering

CQE certification preferred

Job description

Euclid Vision Corporation is seeking a Senior Quality Engineer to design, implement, and lead quality systems ensuring patient safety and product performance. You will act as SME for internal and third-party audits and support regulatory readiness across ISO 13485, GMP, GDP, and 21 CFR 820.

Reporting to the Director of Quality Assurance, you will drive CAPA, validation, and risk management while partnering with cross-functional teams to improve processes and product quality.