Quality Engineer III

Bausch + Lomb•US-NY-Rochester, NY

4d•Onsite

About The Position

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. The position provides technical leadership across the product lifecycle, including design transfer, process validation, manufacturing, and postmarket quality activities, ensuring alignment with Bausch + Lomb global standards and regulatory expectations. The Senior Quality Engineer partners cross-functionally to implement risk based decision-making, support new product introductions, and lead quality improvement initiatives to enhance product performance, compliance, and operational efficiency.

Requirements

Bachelor's degree in science or related field required.
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
Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Nice To Haves

Master's degree preferred.
Experience with MES, statistical software, or data visualization tools (Minitab, Power BI, AI)

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