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.
Provide support for development projects from project inception through successful Technology Transfer/Scale-Up at the manufacturing facility.
The role includes working with multidisciplinary teams to ensure medical device development and remediation activities are planned and executed in compliance with design control requirements of Bausch + Lomb quality management system, ISO, FDA, and other regulatory agencies.
Additionally, this role has oversight of the development and maintenance of contact lens device history & risk management files for all assigned products.The role will support marketed product changes and updates (MOB). Represent design quality on new contact lens product development and/or device maintenance of business (MOB) teams.
Duties will include:
* Ensure project plans comply with B&L, FDA, other regulatory agency, and ISO design control requirements.
* Ensure projects adequately meet design, development, technology transfer, validation, and post launch requirements in accordance with the corporate product development process (PDP).
* Drive and apply Advanced Quality Planning principles for new product/manufacturing process development activities to ensure effective, efficient and complaint transfer to manufacturing operations.
* Manage the documentation of product design control activities (i.e. DHFI, etc.)
* Manage product risk management requirements per ISO 14971.
* Review and approve R&D equipment qualification protocols, product/process specifications, analytical method qualifications, development engineering protocols, validation strategies/protocols/reports, clinical trial material protocols & batch records, QCRs etc.
* Issue QA Product Release authorizations for new products
* Complete and provide risk management and/or complaint data updates to annual Product Quality Reviews (PQR), revisions to Design Risk Analysis, and input to Clinical Evaluation Reports.
* Support post launch design changes as required.
* Support R&D development laboratory from a quality management perspective
* Support internal and external audits as a design quality subject matter expert. This includes providing front room and/or back room support as required.
* Support R&D / design quality related NC & CAPA activities
Requirements:
Minimum 5+ years in medical device or pharmaceutical industry in Quality, R&D, Engineering or Laboratory environment
Specific experience desired as follows:
* 5 years in medical device product development
* Risk management experience.
* Familiarity with relevant regulations and standards (i.e., FDA 21 CFR, EU MDD/MDR, ISO-13485, ISO-14971)
* Previous Compliant management, complaint review and corrective action.
* Quality experience in medical device or pharma industry
* Knowledge of structured problem solving, six sigma, and lean tools
Bausch & Lomb is committed to equal employment opportunity and complies with equal employment opportunity laws in effect wherever it operates.