Bausch + Lomb Quality Engineer III in Wilmington, Massachusetts
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 worldfrom 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.
Serve as a Quality ambassador to improve awareness, visibility and communication on quality initiatives and to support assigned departmental, functional, site, divisional and corporate quality goals and priorities within the Specialty Products Vision Care of Bausch + Lomb.
Develop and maintain risk management files and pFMEAs for new processes and process changes.
Support validations for new and existing products, processes and equipment.
Manage NC/CAPA teams through identification and development of corrective action plans, verification and closure.
Coordinate and support supplier quality management activities, including qualification and evaluation, supplier investigations, etc
Manage and support batch record review and disposition of product.
Support and prepare for site-level internal, external, supplier and customer audits.
Apply systematic problem-solving methodologies and provide quality support to identify and resolve quality issues to ensure production of safe and effective medical devices.
Identify and implement opportunities for continuous improvement.
Interact and coordinate activities with other departments, external vendors and customers.
Perform other Quality System related duties as required.
Bachelors degree required, preferably in Engineering, Science (Chemistry, Biology, Physics, etc) or Math (Statistics).
5+years of experience in roles with increasing levels of complexity and scope.
Experience in an FDA regulated manufacturing or industrial environment.
Strong working knowledge of FDA / ISO 13485 Quality System. requirements, GxP, and other relevant standards and regulations.
Technical skills and experience related to process validation, statistical methods, and risk management.
Experience performing quality audits. Certified Quality Auditor (ASQ CQA) or Certified Quality Engineer (ASQ CQE) preferred.
Lean manufacturing / Six Sigma helpul
Strong cross-collaborator, effective coaching and mentoring skills
Ability to work independently, well organized and self-driven.
Excellent written and verbal communication skills.
This position may be available in the following location(s): [[location_obj]]
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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