Quality Assurance Specialist I
Bausch + Lomb France
Summary
The role of Quality Assurance Specialist I is integral to the on-going compliance of the manufacturing and distribution processes. The Quality Assurance Specialist I may be involved in all stages of the product life cycle - Product design, manufacturing support, and post-launch maintenance.
Job description
Objectives/Purpose of Job
The role of Quality Assurance Specialist I is integral to the on-going compliance of the manufacturing and distribution processes. The Quality Assurance Specialist I may be involved in all stages of the product life cycle - Product design, manufacturing support, and post-launch maintenance.
Key Activities
- Participates in efforts in conjunction with manufacturing and engineering to develop plans for continual improvement of product and process quality.
- Ensures that decisions are made based on sound Quality principles and regulatory guidelines.
- Management of nonconformances for assigned areas of QA oversight. Assist/perform failure investigations, using root cause analysis tools, and proposing/implementing systemic corrective actions. Execute CAPA effectiveness verifications to confirm that the corrective actions implemented are effective.
- Trending of key quality metrics, including nonconformances. Preparation of trend reports and presentations for management. Evaluate metrics to identify areas of potential process improvement. Assist in implementation of process improvements.
- Quality oversight of validation activities for assigned areas of oversight, including QA review and approval of validation documentation.
- Create and revise quality related documentation. Review and approval of operations records for assigned areas of quality oversight.
Special Skills
- Detail-oriented and well-organized
- Ability to multi-task and effectively shift priorities as needed to meet operational requirements and customer demand
Requirements
- Bachelor's degree (BA/BS) in life sciences, physical sciences, engineering, or a related field
- Experience in Quality Assurance or Quality Control within pharmaceutical or medical device manufacturing
- Familiarity with 21 CFR 210, 211, and/or 820 and ISO 13485
- Strong understanding of GMPs and regulated quality systems
- Ability to trend, analyze, and graph data for presentation to management
- Detail-oriented and well-organized
- Ability to multi-task and effectively shift priorities
Company overview
Bausch + Lomb France is the French subsidiary of the global eye health company Bausch + Lomb, specializing in ophthalmic surgical products and contact lenses. Headquartered in Montpellier, France, the company has been a pioneer in vision care for over 165 years and has been at the forefront of contact lens innovation since introducing the world's first soft contact lenses in 1971. As part of the Bausch + Lomb Surgical division, the French operation focuses on providing comprehensive ophthalmic solutions including intraocular lenses, surgical instruments, viscoelastics, and advanced diagnostic platforms for cataract, retinal, refractive, and corneal surgeries. The company serves healthcare professionals across France with cutting-edge technologies like the Stellaris Elite surgical system, VICTUS femtosecond laser platform, and innovative IOLs such as LuxLife and enVista Envy. Bausch + Lomb France maintains a strong commitment to patient well-being, innovation, and excellence in eye care, supporting ophthalmologists and optometrists with educational programs, surgical symposia, and technical training to advance ophthalmic practice throughout the country.