Quality Engineer II

Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world—from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.

Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.

Objective:

• Quality Engineer II provides quality engineering support to ensure product compliance and processes throughout the product lifecycle, including development, manufacturing, and post-market in medical device regulated environment.
• This position partners closely with Manufacturing, Engineering, R&D, Supply Chain, and Quality Operations to ensure products and manufacturing processes consistently meet established specifications, quality system requirements, and applicable medical-device regulatory requirements for release of Intraocular Lens (IOL) and Insertion Devices.

Responsibilities:

Manufacturing Quality Support

• Provide day-to-day quality engineering support for IOL and Inserter manufacturing, inspection, testing, packaging, and related operations.
• Evaluate manufacturing quality issues and provide timely quality-engineering guidance to Operations and Engineering.
• Review Lot History Records (LHRs) and evaluate production issues to confirm adherence to established product and process quality requirements.
• Review and support disposition of nonconforming materials, components, work-in-process, and finished product.
• Assess manufacturing deviations and nonconformances for product-quality and patient-risk implications.
• Monitor manufacturing trends and identify opportunities to improve product quality, process consistency, and yield.
• Supports the complaint investigation process. Interacts with Global Complaint Management group and other functions to investigate and as appropriate initiate corrective actions for complaints.

Investigation, CAPA and Process Improvements

• Support investigations involving process excursions, specification failures, inspection failures, and recurring manufacturing defects.
• Lead or support investigations using structured root-cause analysis methodologies such as 5 Whys, Fishbone/Ishikawa analysis, fault-tree analysis, and data-driven troubleshooting.
• Partner with manufacturing teams to identify and implement effective corrective actions while maintaining compliance with approved procedures and specifications.
• Develop and evaluate corrective and preventive actions (CAPAs) to address systemic quality issues.
• Establish appropriate effectiveness checks and evaluate objective evidence to confirm corrective actions remain effective.
• Perform trend analysis of nonconformances, defects, deviations, complaints, and other quality indicators as applicable.
• Escalate significant or recurring quality issues in accordance with established quality-system requirements.

Process Validation and Qualification

• Review and/or approve validation protocols and reports, including IQ/OQ/PQ/PV activities, as applicable
• Evaluate proposed manufacturing and process changes for validation, documentation, and quality-system impact.
• Provide quality-engineering support for manufacturing transfers, new or modified equipment, new processes, and product/process changes.
• Support product and manufacturing-process risk-management activities throughout the product lifecycle process.

Quality System and Compliance

• Support internal, external, customer, and regulatory audits by preparing objective evidence and responding to auditor questions within assigned areas.
• Maintain audit readiness through routine record and compliance reviews; support investigation, corrective-action implementation, timely responses, and closure of audit observations.
• Communicate quality issues, risks, investigation status, and recommendations clearly to technical teams and management.
• Provides routine analysis of performance indicators (yield, NCs, Complaints, etc.) and identifies trends.  Presents this information to management, supervisors, and manufacturing operators during Management Review and Annual Product Review.

Change Control and Risk Management

• Initiate, prepare, review, and approve Quality Change Requests (QCRs), Document Change Requests (DCRs), process deviations, and quality-system changes; participate in Local Change Board (LCB) reviews as the Quality representative.
• Perform documented risk assessments for nonconformances, CAPAs, manufacturing processes, equipment, and quality-system changes.

Qualifications:

Required Education:

• Bachelor’s degree (BS) in engineering or equivalent science degree.

Required Experience:

• Minimum of 3 years of Quality Engineering experience supporting medical device and/or pharmaceutical manufacturing.

Preferred Experience:

• Experience in medical-device manufacturing, preferably ophthalmic, implantable, sterile, or other highly controlled products.
• Knowledgeable of ISO 13485 and FDA/QSR requirements and quality system development and management.
• Knowledge of statistical techniques and application experience.
• Demonstrated project management and leadership skills, strong written and oral communication and interpersonal skills.
• Working knowledge of FDA regulatory necessary experience with managing external agency audits necessary.
• Training in problem solving tools is required (Process Mapping, Histograms, FMEA, Risk Assessment, Cause & Effect Diagrams, PCDA, Pareto Analysis)
• Strong Computer & Information Technology Skills (Windows, Word, Excel, Access, Power Point, Project, Visio, statistical software usage & principles.) 

This position may be available in the following location(s): US - Clearwater, FL

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.

Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

To learn more please read Bausch + Lomb's Job Offer Fraud Statement

Our US Benefit Programs Employee Benefits: Bausch + Lomb

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.

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