Job Information
Bausch + Lomb Quality Engineer II in Rochester, 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 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.
Position Objectives
To provide technical support of Departmental Technical Documentation activities and the development, implementation and effectiveness of Development Process Engineering's (DPE's) procedures and systems for compliance to the quality directives. This includes but is not limited to gap assessments of directives and DPE's processes and procedures, training. procedure effectiveness, metrics for tracking performance, qualification and validation support of equipment, facilities and software, conducting risk assessments, technical writing and electronic filing and storage of information. Support internal audits and corrective actions.
Responsibilities
Support Process Engineering Lab Quality Directives gap analysis and closure plan execution.
Help perform risk assessments, investigations, documentation and procedure updates. qualification writing and execution.
Drive effort to manage DPE's SOPs to ensure GMP, FDA, and ISO compliance.
Support Compliance and Documentation Systems for OPE (Global Document Management System) for protocols/reports and procedures; CATSWeb for non-conformances and CAPAs; Compliance Wire Learning Management System for training; Kintana for change control.
Conduct risk assessments as they pertain to Quality System compliance.
Support systems for PMs , Calibration, Environmental Monitoring, and storage of clinical trial materials and products.
Manage and maintain the Master Validation Plan for the qualification and requalification of equipment, facilities and software.
Requirements
Degree in Science/Engineering with Quality Engineering experience and/or certification as a Quality Engineer.
Specialized Training: IS0-9000, GMP, medical device manufacturing experience, technical writing. equipment and software qualification documentation, Lean/Six sigma. clean room compliance.
3-9 years experience in a technical organization, Regulated Medical Device or Pharma industry a plus. Minimum of 3 years experience with medical device and/or clean room environment compliance regulations required.
Special Skills: Computer competent with Microsoft Office suite; ability to learn specific software systems utilized in B&L's growing Quality Systems (Documentum, Kintana, CATSWeb). Actively participate in Process and Design FMEA activities as required. Use and knowledge of Lean and DFSS tools and software desired. Communication, Organization, Report Writing as must. Must be able to develop working relationships with various internal core competencies and work as a team member.
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
This position may be available in the following location(s): [[location_obj]]
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 salary for this role is $70,000 to $105,000.
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.
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