Senior Quality Engineer

Senior Quality EngineerSee 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 RoleReal 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 DoLead and shape quality policies, procedures, and systems that meet ISO 13485, GMP, GDP, and 21 CFR 820 standardsDrive root cause analysis, CAPA, and continuous improvement efforts across cross-functional teamsOwn validation protocols for software, equipment, processes, and test methodsApply statistical analysis, risk management, and FMEA practices to strengthen manufacturing operationsSupport new product development and manufacturing transfers with a quality-first lensTrain and mentor colleagues on quality processes, elevating the team around youRepresent Quality as a subject matter expert in audits and management reviewsWhat You BringB.S. in Engineering (or equivalent) with CQE certification preferred5–7 years of Quality Engineering experience — medical device background strongly preferredHands-on CAPA process experience, start to finishWorking knowledge of GMP, GDP, ISO 13485, and 21 CFR 820Strong analytical and problem-solving skills, with the organizational chops to juggle multiple prioritiesA collaborative communicator who can influence across all levels of the organizationBonus points: Six Sigma, FMEA, SPC, or Validation Program experienceEqual Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.