Senior Quality Engineer

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

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

Equal Opportunity Employer

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