Quality Engineer III

Objectives

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 applicable Quality Management System (QMS) requirements, including ISO 13485 and FDA 21 CFR Part 820, while driving continuous improvement in product and process quality.

Key Activities/Responsibilities

• Ensure compliance with QMS requirements, including:
• Nonconformance (NC) management and CAPA systems
• Change control and validation activities
• Document review and approval (DHRs, SOPs, specifications)
• Provide quality oversight for:
• Contact lens product lifecycle
• Process validation (SAT/FAT/IQ/OQ/PQ/PV)
• Statistical sampling plans and data analysis
• Design transfer activities in accordance with design control requirements
• Drive root cause investigations using structured methodologies:
• PdCA, 5y, DMAIC, 8D, Fishbone, etc.
• Ensure timely and effective containment, correction, and prevention
• Perform data analysis and trending to:
• Identify emerging risks and quality signals
• Support decision-making through statistical tools
• Lead risk management activities aligned with ISO 14971, including:
• PfMEA development and maintenance
• Risk assessment, mitigation, and verification
• Act as a quality lead for continuous improvement initiatives:
• Reduce scrap, defects, and cost of poor quality (COPQ)
• Improve manufacturing capability and process robustness
• Ensure audit readiness and participate in:
• Internal audits
• External regulatory inspections (e.g., FDA, notified bodies)
• Collaborate with cross-functional teams (manufacturing, engineering, R&D, supply chain) to:
• Resolve quality issues
• Support product lifecycle activities
• Ensure alignment with design and regulatory requirements
• Mentor junior engineers, quality technicians, and provide technical guidance to operations personnel and peers

Qualifications/Training

• Education: Bachelor's degree in science or related field required. Master's degree preferred.
• Minimum 10 years of relevant experience in Quality or Engineering in a medical device or regulated industry
• Strong working knowledge of:
• ISO 13485
• FDA 21 CFR Part 820
• Risk Management (ISO 14971)
• Experience with:
• CAPA and nonconformance systems
• Process validation and statistical analysis
• Lean Six Sigma methodologies (Green Belt or Black Belt preferred)
• Demonstrated ability to:
• Lead and work with cross-functional teams
• Influence decision-making without direct authority
• Communicate effectively with internal stakeholders and external auditors
• Experience with:
• MES
• Statistical software
• Data visualization tools (Minitab, Power BI, AI)