Bausch + Lomb Quality Engineer in Midtown, New York
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 nearly 170-year history. We have a significant global research, development, manufacturing, and commercial footprint of approximately 12,500employees 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.
Performs activities to support and improve product and process quality, and ensure compliance with regulations, standards, and regional and local procedures at the Lancaster, NY contact lens manufacturing site.
Supports Device History Record review and product release. Has the authority to place products or processes on hold and to disposition product (release or scrap).
Supports the document management and records management systems including document change approval, review, and distribution. Authors and revises procedures as needed.
Performs supplier management activities, including supplier qualification, audits, and investigations. Supports quality inspection of incoming materials, as needed.
Performs or supports nonconformance, CAPA, and product complaint investigations.
Supports risk management activities, including management of pFMEAs.
Reviews and approves production and process control, maintenance/calibration, validation, design, and risk management records as needed.
Supports administration of the training management system.
Participates in internal audits, which may include scheduling, auditing, preparation of reports, and follow-up activities.Supports corporate and external audits, including preparation, fulfilling auditor requests, and follow-up activities.
Collects and analyzes data for the reporting of Quality Performance Indicators, and in preparation for Management Reviews and other periodic reviews.
Identifies and implements opportunities for continuous improvement.
Participates in other business-related projects and activities upon request of management.
Bachelor’s degree, preferably in a technical field
4+ years of quality assurance experience in a medical device or other regulated industry.
Ability to work independently, well-organized, self-driven.
Excellent investigative and problem-solving skills.
Detail-oriented and accurate approach to tasks.
Excellent verbal and written communication skills.
Team player with interpersonal skills.
Proficiency with Microsoft Office applications and online meeting platforms.
Familiarity with FDA regulations and ISO standards, preferably medical device regulations and ISO 13485.
Experience with statistical analysis and/or Lean/Six Sigma.
Experience with performing quality audits.
New York State:
As required by New York State's pay transparency bill, Bausch + Lomb provides a good faith minimum and maximum salary range of compensation for roles that can or will be performed, in New York State. Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location. For New York State, the range of starting annual base pay for this role is $65,000- $100,00
This position may be available in the following location: Lancaster, NY
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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