Senior Quality Assurance 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. 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
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