Senior Quality Engineer

About the Role

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.

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
• 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

Requirements

• 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

Skills

Bonus points: Six Sigma, FMEA, SPC, or Validation Program experience