Quality Engineer III

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 Equipment 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 Equipment Value Stream.

• 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 final product inspection, testing, and release. 

• May supervise quality control functions (receiving, in-process inspection, product final release, calibration program, and complaint evaluation)

• Responsible for Product Quality Assurance and Quality Engineering at the Equipment 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 Equipment Value Stream.

• 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 final product inspection, testing, and release. 

• May supervise quality control functions (receiving, in-process inspection, product final release, calibration program, and complaint evaluation).

• Knowledge and experience in the application of 21CFR820, ISO 13485, MDR, MDSAP, and IEC60601.
• Knowledge and experience in design control and  V&V for Systems, Software, components, accessories and the associated critical fabrication and assembly processes.
• Knowledge and experience in DFSS especially critical parameter management, boundary condition testing, tolerancing for high process capability and performance sustainability resulting in specifications and process controls that can easily be transferred and sustained in manufacturing and especially at suppliers and CMOs.
• Experience in Product Stewardship – engaging stakeholders from R&D, Medical Affairs, Commercial team for VOC, operations, RA etc… to maintain comprehensive understanding of product performance – from manufacturability, serviceability to customer useability.
• Business Acumen – can translate business objectives to quality strategy and can justify quality sytems and process in terms of business effectiveness and efficiency.
• Strong people skill – ability to effectively and humbly listen to stakeholders and peers, synthesize information, formulate and articulate insights to influence positive outcomes.  A strong sense of urgency and agility to establish solutions.
• Leadership skills – aspires to gain scope of accountability by developing and supporting others to achieve more collaboratively while growing competencies and ability in other team members.

Responsibilities:

CAPA:

• 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 and complaint data to identify any necessary CAPA activities. 

Quality Systems:

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

Process Controls:

• Monitor product quality through inspection, testing, and auditing.
• Ensure Device History Records are maintained in compliance with FDA requirements.

Metrics Management:

• 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.

Product Surveillance:

• Assist in Product Complaint evaluations and investigations.

Special Quality Projects:

• Identify, own, and lead Quality projects in collaboration with other site resources, primarily focused in 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 3+ years of experience in the Quality Assurance field working with ISO 13485, FDA Quality System Regulations, and Medical Device Directive requirements.
• Minimum 1 year utilizing corrective and preventive action (CAPA) system, in compliance with US federal and international regulatory standards relating to medical devices.
• Minimum 1 year experience in Nonconforming Product Management.
• Minimum 1 year experience in Complaints investigation.
• Minimum 1-year Utilization of root cause analysis tools, including fishbone diagrams, fault tree analysis, 5 Whys, Is/Is Not.

• 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.

Preferred Qualifications:

• Experience working in an electro-mechanical assembly manufacturing environment.
• Specialized Training:  FDA GMP training; Basic statistical including trends, pareto and other basic charting techniques.
• Training with basic statistical including trends, pareto and other basic charting techniques.
• Desirable Lean Six Sigma Green Belt Certification.

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.

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.

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