Job Description
Bausch + Lomb, a leading global eye health business is solely focused on making people see better to live better. The company has over a 40-year track record of growth and diversification in Waterford Irelands oldest city. From Waterford, Bausch + Lomb supplies eye health products to people across the world. The companys success in Waterford has been built on a great team who between them have thousands of years of experience of delivering the highest quality every time. As the facility has grown, new opportunities have been created for skilled people to join the team and take their careers to the next level in a global company with deep local roots in Waterford. The Senior Design Quality Engineer is a member of the Global R&D Quality department and plays a key role in ensuring that the Quality System functions are maintained in compliance with documented procedures. As Senior Design Quality Engineer, you will work primarily on New Product Development projects, collaborating with all functions on all aspects of our integrated innovation process including supporting introduction of new products and processes following stage-gate methodology, risk identification & control and serve as the Voice of the Customer during the full end-to-end product innovation cycle - from concept through feasibility, development & commercialisation. This global position reports to the Senior Manager of Design Quality (Vision Care) and the role is based in Waterford. Key Duties & Responsibilities Provide support for development projects from project inception through successful Technology Transfer/Scale-Up at the manufacturing facility. The role includes working with global multidisciplinary teams to ensure medical device development and remediation activities are planned and executed in compliance with design control requirements of Bausch + Lombquality 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). The role will alsosupport R&D plant activities along with development laboratory from a quality management perspective Requirements Minimum 5+ years in medical device or pharmaceutical industry in Quality, R&D, Engineering or Laboratory environment. Specific experience desired as follows: Risk management experience. Familiarity with relevant regulations and standards (i.e.ISO-13485, ISO-14971, FDA 21 CFR, EU MDD/MDR) Quality experience in medical device or pharma industry Knowledge of structured problem solving, six sigma, and lean tools