Quality Engineer III

Role Overview

The Senior Quality Engineer serves as a key Quality Assurance representative for contact lens manufacturing operations at the Rochester, NY facility. This role is accountable for ensuring compliance with QMS requirements, including ISO 13485 and FDA 21 CFR Part 820, while driving continuous improvement in product and process quality. The engineer provides technical leadership across the product lifecycle, supporting new product introductions and quality improvement initiatives.

• Ensure compliance with QMS requirements, including nonconformance management, CAPA, change control, and document review.
• Provide quality oversight across the contact lens product lifecycle, process validation, statistical sampling, and design transfer activities.
• Drive root‑cause investigations using structured methodologies such as PDCA and DMAIC, and implement containment, correction, and preventive actions.
• Perform data analysis and trending to identify emerging risks and support decision‑making through statistical tools.
• Lead risk‑management activities aligned with ISO 14971, including PFMEA development, risk assessment, mitigation, and verification.
• Act as a quality lead for continuous‑improvement initiatives to reduce scrap, defects, and cost of poor quality, and improve manufacturing capability.
• Ensure audit readiness by participating in internal audits and external regulatory inspections.
• Collaborate with cross‑functional teams (manufacturing, engineering, R&D, supply chain) to resolve quality issues and support product lifecycle activities.
• Mentor junior engineers, quality technicians, and provide technical guidance to operations personnel and peers.

• Bachelor’s degree in science or related field (Master’s preferred).
• Minimum 10 years of relevant experience in quality or engineering within a medical device or regulated industry.
• Strong working knowledge of ISO 13485, FDA 21 CFR Part 820, and ISO 14971 risk management.
• Experience with CAPA systems, nonconformances, process validation, statistical analysis, and Lean Six Sigma (Green Belt or Black Belt preferred).
• Demonstrated ability to lead and work with cross‑functional teams, influence decision‑making without direct authority, and communicate effectively with stakeholders and auditors.
• Experience with MES, statistical software, and data visualization tools (e.g., Minitab, Power BI).

The estimated salary range is $95,200–$128,800. U.S. employees may receive short‑term and/or long‑term incentives, medical, dental, vision, disability, and life insurance, a 401(k) plan with company match, tuition reimbursement for select degrees, company holidays, well‑being benefits, sick time, floating holidays, and paid vacation.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Applicants must be authorized to work for any employer in the United States. The company is unable to sponsor a work visa.