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Bausch + Lomb Principal Quality Engineer (Medical Device) in Saint Louis, Missouri

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:

Establish site implementation of Bausch + Lomb St. Louis QMS. Establish a sustained culture of Quality through cross-functional engagement and collaboration. Partner with Site Operations Leader and Engineering to establish and sustain a compliant and agile change management and production management system to meet business objectives. Ensure compliance with applicable regulations and standards, as well as in accordance with internal B+L policies and procedures. Report on the performance of the quality systems for Management Review and other periodic reviews. Responsible for ownership and/or support Corrective and Preventive Actions, Non-conforming Materials, and Product Complaint process at the site and ensuring effectiveness of quality improvements and validation activities as part of the CAPA process. Manage processing of materials through finish product release. May supervise quality control functions (receiving, in-process inspection, product final release and complaint evaluation). Ensure products are of high quality and meet the required product specifications while demonstrating full commitment to patient safety and compliance to requirements.

Responsibilities:

Management

Quality Leader at the Instruments site. Manage Value Stream's Quality Team of Technicians. Support individual development of team members and provide performance evaluations. Act as Product Steward for the Value Stream (full product lifecycle responsibility).

CAPA / NC

Develop, establish, and maintain system for corrective and preventative actions and lead/participate in CAPA and NC projects. Drive quality data analysis and coordinate activities to make product and process improvements.

Internal Audits

Support internal audit system. Participate in internal audits as auditee, SME, or Auditor. Support / lead corrective action activity.

Quality Systems (other)

Develop, establish and maintain quality assurance programs, policies, processes, procedures and controls assuring that performance and quality of products conform to established standards and agency regulations.

Process Controls / Design Controls

Monitor product quality through inspection, testing, and auditing. Enforce statistically sound programs for sampling and process validations. Monitor environmental control, process validation and process monitoring methods, where applicable. Provide input into Design Control activities for new/changed product designs.

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

Lead / Assist in Product Complaint evaluations and investigations.

External Audits

Lead / Participate in external inspections/audits (i.e., FDA, EU Notified Body, MDSAP, LGA, UL, ETL, & CSA) at the St. Louis Sites.

Change Management

Support and lead Change Management activities associated for the Value Stream.

Projects

Support projects related to Value Stream including process / product validation, capital expenditure proposals, etc.

Requirements:

  • Bachelor of Science Degree in Engineering, Related Science Field, Business, or equivalent experience.

  • Minimum 3 years experience in medical device manufacturing.

  • Minimum 5 years experience in Quality Assurance.

  • Experience with root cause analysis tools and CAPA.

  • Demonstrated experience/aptitude in leading Quality team and culture.

  • Process validation; statistical process control, problem solving, project management, FDA GMP and / or ISO QMS training.

Preferred Qualifications:

  • Knowledge of Lean Manufacturing or Continuous Improvement Methodologies.

  • Master's Degree in Engineering, Science, or Business.

  • American Society for Quality (ASQ) certification and / or Lean Six Sigma belt.

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/Bausch_job_posting_statement.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.

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