IE Waterford Quality Assurance Shift Engineer

Job description

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. Scope of Position The Quality Assurance Shift Engineer supports the Manufacturing QA Manager in ensuring that manufacturing produces product that meets specification in an environment compliant with all relevant standards. This is a shift position. Key Activities / Responsibilities Determine appropriate lot-disposition decisions on a shift-by-shift basis. Manage, review and approve non-conformances. Provide quality oversight for manufacturing, including approval of validation documentation, preparation and update of applicable PFMEAs, CAPA activity and continuous improvement. Act as the Manufacturing Quality Management interface with operations and engineering. Disposition product as appropriate and manage non-conformance activity. Highlight relevant issues and participate in or lead resolution. Review validation documentation and change requests. Participate in Quality System continuous improvement activities. Ensure compliance with applicable GMP and medical-device regulatory requirements, including FDA, ISO, MDD & MDR requirements, and internal documentation. Provide direction to ensure product quality is maintained at all stages of manufacturing. Provide shift direction on QASL issues. Complete non-conformance rationales as required. Complete additional requirements specified by the Manufacturing Quality Manager. Follow Standard Operating Procedures at all times. Maintain awareness of applicable standards and QMS requirements. Follow gowning procedures and entry rules for manufacturing and controlled areas. Follow Personal Hygiene Rules defined in the GMP Training Programme and notify supervision of health conditions that may affect product quality. Maintain a clean and tidy work area. Key Relationships Production colleagues Production managers Maintenance technicians Warehouse colleagues Process Excellence Department Training Department QA Department Engineering Department HR Department R&D Department Qualifications / Training Minimum three years' experience in a regulated pharmaceutical or medical-device environment. Full understanding of regulatory-standard requirements. Third-level qualification, ideally in Engineering or Science. Strong analytical skills and good knowledge of process-control systems. Knowledge of Six Sigma and Lean tools. Self-motivated and able to manage multiple priorities. Decisive, effective communicator, self-motivated, achievement-focused and a strong team member. Microsoft Office experience. Bausch & Lomb is committed to equal employment opportunity and complies with equal employment opportunity laws in effect wherever it operates. Apply now » Find similar jobs: 바슈앤롬, Carrières chez Bausch & Lomb, Carreras Bausch & Lomb, Bausch und Lomb, Bausch & Lomb Contact Us Legal Notice Privacy Policy Site Map E- Verify Poster Right to Work Opens in a new tab. Opens in a new tab. Cookie Consent Manager When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. Because we respect your right to privacy, you can choose not to allow some types of cookies. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer. Required Cookies These cookies are required to use this website and can't be turned off. Required Cookies Required Cookies Provider Description Enabled SAP as service provider We use the following session cookies, which are all required to enable the website to function: "route" is used for session stickiness "careerSiteCompanyId" is used to send the request to the correct data center "JSESSIONID" is placed on the visitor's device during the session so the server can identify the visitor "Load balancer cookie" (actual cookie name may vary) prevents a visitor from bouncing from one instance to another Cookies from provider SAPasserviceprovider are required and cannot be turned off