Principal Engineer (Quality)

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.Objectives:Responsible for Product Quality Assurance and Quality Engineering at the Disposable Packs department. Provide technical oversight and maintain quality systems that are effective and comply with federal, state, local, and other applicable international regulations, and standards, as well as in accordance with internal Bausch & Lomb policies and procedures for the St. Louis site Disposable Value Stream. Provide technical oversight for cleanroom and terminal sterilization (Gamma & ETO) processes. Lead the controlled/clean room Environmental Monitoring process and performance. Report on the performance of the quality system to the St. Louis site management. Coordinate product nonconformance process and reports (NCRs). Support product/process changes and new product launch. Responsible to own and/or support Corrective and Preventive Actions (CAPA), relative to the specific area of responsibility and/or products. Monitor the effectiveness of quality improvements, and validation activities as part of the CAPA process requirements. Manage quality assurance activities related to processing of materials through finish product inspection, testing, and release. May supervise quality control functions (receiving, in-process inspection, product final release, and complaint evaluation). Specific focus on Environmental Monitoring, Sterilization, Clean Room Procedures, Root Cause Analysis and Validation.Responsibilities:

Drive quality data analysis (fishbone diagrams, pareto analysis, etc.) and coordinate activities to make product and process improvements. Review sources of Quality Data including process yields, complaint data and Environmental Monitoring reports to identify any necessary CAPA activities.

Develop and maintain quality assurance procedures and work instructions regarding inspection and data gathering/analysis.

Monitor product quality through inspection, testing, and auditing. Monitor environmental control, process validation, and sterilization methods, where applicable.

Ensure Device History Records are maintained in compliance with FDA requirements.

Work with operating entities to establish and maintain procedures for inspection, process control, data analysis and product conformance. Issue reports on KPIs to appropriate management.

Assist in Product Complaint evaluations and investigations.

Identify, own, and lead Quality projects in collaboration with other site resources, primarily focused on the improvement of Quality processes and efficiency in alignment to Operational Excellence and business goals.

Requirements:

Bachelor of Science Degree in Engineering or related science field (or equivalent experience).

Minimum 5 years of experience in the Quality Assurance field working with ISO 13485, FDA Quality System Regulations, and Medical Device Directive requirements.

Minimum 5 years of working experience in a Quality Assurance/Quality Engineering role specifically with disposable Medical Devices manufactured at a compliant controlled or clean room environment.

Minimum 5 years experience with responsibility to ensure compliance to technical standards and regulations for environmental monitoring of controlled Rooms.

Minimum 5 years experience supporting validation of sterilization processes and continuous monitoring of products sterilization status prior to quality release for shipment.

Minimum 3 years utilizing corrective and preventive action (CAPA) system, in compliance with US federal and international regulatory standards relating to medical devices.

Minimum 3 years experience in Nonconforming Product Management.

Minimum 3 year experience in Complaints investigation.

Minimum 3 years in utilization of root cause analysis tools, including fishbone diagrams, fault tree analysis, 5 Whys, Is/Is Not.

Preferred Qualifications:

Experience working in a Cleanroom environment.

Working knowledge of Sterilization methodologies (Gamma & ETO) and basic knowledge of sterilization validation.

Experience working with FDA GMP’s and ISO 13485 Quality System Regulations.

Specialized Training: FDA GMP training; Sterilization techniques (Gamma & ETO); Cleanroom operations and monitoring.

Formal training and working experience with ISO 14644 requirements, EU GMP for Clean Rooms, and ISO Class 7 and 8 certified rooms.

Desirable Lean Six Sigma Green Belt Certification

Basic microbiology, process validation; statistical process control, root cause investigation, and use of problem-solving tools.

Basic knowledge of Lean Manufacturing and Continuous Improvement concepts and tools.

Basic knowledge of applicable requirements to Environmental Monitoring of Controlled Rooms for Medical Devices manufacturing.

Fundamental knowledge of Gamma radiation and Ethylene Oxide sterilization processes.

We offer competitive salary & excellent benefits including:

Medical, Dental, Eye Health, Disability and Life Insurance begins on your hire date

401K Plan with company match and ongoing company contribution

Paid time off – vacation (3 weeks - prorated upon hire), floating holidays and sick time

Employee Stock Purchase Plan with company match

Employee Incentive Bonus

Tuition Reimbursement (select degrees)

Ongoing performance feedback and annual compensation review

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 (https://hcm2preview.sapsf.eu/bauschhealT4/Bauschjobpostingstatement.docx) .Our Benefit Programs: https://www.bausch.com/careers/benefits/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.