Senior Quality Engineer

Euclid Vision Corporation; Sterling (VA); On-site; USD 120,000 - 150,000; Full time

Job summary

Euclid Vision Corporation is seeking a Senior Quality Engineer in Sterling, VA to build, improve, and lead quality systems that protect patient safety and product performance. This role reports to the Director of Quality Assurance and is ideal for a hands-on problem solver who thrives at the intersection of engineering rigor and regulatory excellence.

You will lead CAPA reviews, drive root cause investigations, and own quality outcomes across development, validation, and manufacturing transfer,

Qualifications

• B.S. in Engineering or equivalent; CQE preferred.
• 5–7 years of Quality Engineering experience in medical devices.
• Hands-on CAPA process experience from start to finish.
• Familiarity with GMP, GDP, ISO 13485 and 21 CFR 820.
• Strong analytical and communication skills.

Responsibilities

• Lead and shape quality policies, procedures, and systems for compliance.
• Drive CAPA, root cause analysis, and continuous improvement.
• Own validation protocols for software, equipment, and processes.
• Support audits and management reviews as Quality SME.
• Mentor colleagues and collaborate with engineering and manufacturing.

Skills

CAPA process experience

GMP/GDP/ISO 13485/21 CFR 820 knowledge

Root cause analysis

Cross-functional collaboration

Analytical problem-solving

Six Sigma

FMEA

SPC

Education

B.S. in Engineering

CQE certification

Job description

Job Details

Description

See the impact of your work — in the eyes of patients everywhere.
Euclid Vision Corporation is a growing medical device organization specializing in orthokeratology contact lenses that change how people see the world — literally. As we scale across our group of companies, we're looking for a Senior Quality Engineer who wants more than a QA checklist — someone who wants to build, improve, and lead quality systems that directly protect patient safety and product performance. This role reports directly to the Director of Quality Assurance.
If you're a hands-on problem solver who thrives at the intersection of engineering rigor and regulatory excellence, this is your next challenge.

Why This Role

• Real ownership. You won't just review documents — you'll lead CAPA reviews, drive root cause investigations, and own quality outcomes across product development, validation, and manufacturing transfer.
• Visible impact. Partner with the Director, Quality Assurance to achieve site KPIs, present to management, and see your process improvements translate directly into our portfolio of products.
• Cross-functional influence. Partner with engineering, manufacturing, and leadership teams — and build the kind of influence skills that accelerate careers.
• A team that values expertise. You'll be the go-to SME for internal and third-party audits, trusted to represent quality with confidence and credibility.

What You'll Do

• Lead and shape quality policies, procedures, and systems that meet ISO 13485, GMP, GDP, and 21 CFR 820 standards
• Drive root cause analysis, CAPA, and continuous improvement efforts across cross-functional teams
• Own validation protocols for software, equipment, processes, and test methods
• Apply statistical analysis, risk management, and FMEA practices to strengthen manufacturing operations
• Support new product development and manufacturing transfers with a quality-first lens
• Train and mentor colleagues on quality processes, elevating the team around you
• Represent Quality as a subject matter expert in audits and management reviews

What You Bring

• B.S. in Engineering (or equivalent) with CQE certification preferred
• 5–7 years of Quality Engineering experience — medical device background strongly preferred
• Hands-on CAPA process experience, start to finish
• Working knowledge of GMP, GDP, ISO 13485, and 21 CFR 820
• Strong analytical and problem-solving skills, with the organizational chops to juggle multiple priorities
• A collaborative communicator who can influence across all levels of the organization
• Bonus points: Six Sigma, FMEA, SPC, or Validation Program experience