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: 

The primary objective of the Quality Engineer is to assure that products produced and components used are of high quality and meet the required product specifications while demonstrating full commitment to patient safety and compliance to Quality System and regulatory requirements.

Responsibilities:

• Support all aspects of Quality within assigned Value Stream(s).
• Partner with Value Stream leadership (Engineer, Manager, etc.) to ensure compliance to Synergetics Quality System, ISO, and regulatory requirements.
• Investigates customer complaints/field failures and develops corrective action plan where necessary.
• Lead Material Review Board activities related to assigned value stream.
• Participate in CAPA process by leading individual assigned CAPA projects.
• Generate test protocols, monitor/perform testing, and issue/approve qualification test reports.
• Act as single point of contact for Quality related issues for OEM partners including development of PPAP submissions, change requests (SCARF, etc.), and corrective action activities.
• Participate in design reviews and new product validation as Quality Representative.
• Reviews new design specifications and provides input from quality and manufacturability perspective.
• Interact routinely with Product Management, Engineering, Production, and Suppliers to proactively improve quality of products.
• Provide quality and reliability analysis on Value Stream products.
• Manage and develop metrics and prepare trend reports related to Value Stream performance.
• Perform internal and supplier Quality Systems audits.
• Provide support for Supplier Quality Management program through partnership with Supplier Quality Engineer and Purchasing Manager.
• Develop and maintain product inspection criteria based upon sound statistical techniques.
• Develop new work processes, new tools, and new functional capabilities.
• Provide training to all levels of organization and suppliers.
• Ensure proper execution of quality system documentation and support compliance to ISO requirements within QC department.
• Review and approve quality system documentation as necessary.
• Ensure utilization of appropriate statistical techniques.
• Ensure compliance to CFR and ISO guidelines during the receiving and issuance of materials; as well as throughout the entire quality system.
• Provide input to support risk management; review FMEAs.
• Support and participate in FDA & notified body audits and submissions.
• Support internal corporate compliance audits and reporting.
• Lead and participate in OEM customer audits aligned with assigned Value Stream.
• Make presentations on the status of project initiatives to all levels of the organization.
• Manage and influence those that do not have a direct reporting relationship in order to successfully complete projects and initiatives.
• Support the lean initiative by leading and participating in Kaizen events and other lean activities.
• Work with management to understand the compliance risks to the business and potential mitigations to those risks.
• Ensure adherence to all company policies, rules, procedures, and housekeeping standards.
• Perform special projects as required by business needs.

Requirements: 

• Bachelor of Science in Engineering, Biology, Chemistry or other field of science, Certificate of Education in the medical or science discipline; or equivalent experience.
• Minimum 5 years in a quality or operations environment. 
• Knowledge and understanding of the FDA Quality System Regulation (21 CFR Part 820) and the ISO Quality System (9001, 13485 or equivalent) documentation requirements.
• ASQ CQA, ISO Lead Auditor certification, or prior audit experience.
• Extensive knowledge and understanding of metrology.
• Knowledge of problem solving tools to address product and process issues (ie, DMAIC, Kaizen events, 5 Why, fishbone diagram, Cause and Effect).

Preferred:

• An advanced degree, certification, or additional professional training.  
• Experience in pharmaceutical, drugs or medical devices.

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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