The Opportunity QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. The Role As we continue to grow as one QuidelOrtho, we are seeking a Manufacturing Engineer I to work in our manufacturing facility. The Manufacturing Engineer I would be the primary technical support for all changes initiated by the contract manufacturer. They provide the technical input to change requests from the contract manufacturer working with cross-functional teams including: R&D, Quality Engineering, Field Service Teams, Procurement, Manufacturing, and Environmental/Safety. The Manufacturing Engineer I will conduct detailed analysis of requests and provide guidance, assistance, and technical solutions to facility the change. This individual will track all changes, attend obsolescence meeting, process non-conformances, review incoming inspection plans, work directly with external suppliers, review work instruction, troubleshoot part problems, and fixture repairs. This person is also a support for part quality issues that may occur at the supplier, the manufacture, or at the customer's site. The Manufacturing Engineer uses knowledge of scientific techniques and Process Excellence to design and develop safe, effective, and efficient processes in support of the company's strategies, goals, objectives and product portfolio. They observe all regulatory requirements (GMP's, ISO, FDA, internal policies) applicable to their area of responsibility and comply with safety / Environmental Requirement and safe working conditions and practices. Typical responsibilities may include evaluating existing manufacturing processes and identifying areas for improvement. Determining problem resolutions and implementing improvements. Developing detailed layouts for equipment, processes, and workflow. Researching and developing new processes, equipment, and products. Developing and implementing cost-saving measures and quality control systems. Ensuring manufacturing processes, equipment, and products comply with safety standards and legal regulations. This position is in Rochester, NY. The Responsibilities
- Drives the disposition and change requests from contract manufacturers that includes R&D and Quality.
- Review specification variance packages for completeness for processing in QuidelOrtho' s Quality and Change Control systems.
- Interact with supplier as needed on specification variances and obtain crucial prioritization.
- Posses the ability to put together a presentation for each change request.
- Understand the Quality Tracking System to process any accepted Spec variances as the change is processed, and tasks are completed and closed in the quality record.
- Provide Red-lines to drawing changes until supplier can adequately provide red-lines.
The Individual Required: