Senior Quality Assurance Engineer

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

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. You'll be the go-to SME for internal and third-party audits, trusted to represent quality with confidence and credibility. 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.

Responsibilities

• 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
• 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
• 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

Qualifications

• B.S. in Engineering (or equivalent) with CQE certification preferred
• 5–7 years of Quality Engineering experience — medical device background strongly preferred

Required Skills

• 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

Preferred Skills

• Six Sigma, FMEA, SPC, or Validation Program experience

Equal Opportunity Employer

Euclid Vision Corporation is proud to be an Equal Opportunity Employer. We believe that great ideas and great products come from great teams — and great teams are built by bringing together people with different backgrounds, perspectives, and experiences.

We are committed to providing equal employment opportunity to all qualified applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, veteran status, marital status, pregnancy, or any other characteristic protected by applicable federal, state, or local law. This commitment extends to every aspect of employment — recruiting, hiring, training, promotion, compensation, and benefits. We evaluate qualified applicants based on merit, qualifications, and business needs, and we are dedicated to creating a workplace where every team member can do their best work and grow in their career.

If you require accommodation during the application or interview process, please let us know — we're happy to work with you to make the process accessible.