At SEKISUI Diagnostics, we help improve patient outcomes by doing what we've always done – focusing on innovating and developing highly accurate diagnostics tests, reagents and systems. In recent years, social and consumer needs for medical care have been diversifying in line with dramatic transformations in the global medical environment. We will continue to embrace change and challenge new frontiers so that we can create unique, high-quality pr...
About you. You are a seasoned professional with over 10 years in the Regulatory Affairs space with specific experience with IVD and POC products. You are known as the Regulatory point of contact as you support regulatory needs in all aspects of the business, from product development, to manufacturing and post market needs. You have experience in the past 5 years with US regulatory affairs submissions such as 510(k) and PMA. You are an approachabl...
. Sekisui Diagnostics, a leader in invitro diagnostics, is seeking an experienced Director of Corporate Development/Business Development to lead business development activities (Mergers & Acquisitions, Partnerships) to achieve our short- and long-term strategic goals and objectives. In this role, you will show case your expertise in all aspects of Business Development and partnering by identifying and securing key business opportunities to augme...
As a. Manufacturing Associate II. you will support and operate manufacturing equipment to meet established production goals. You will be responsible for line inspections and staging materials for specific jobs. The completion and review of process-related documentation is completed to support a commitment to quality standards. Who are you. You are a detail-oriented person comfortable in performing repetitive duties to support general manufacturin...
Who are you. Your strong analytic and critical thinking skills are key to your solution-oriented approach to integrating quality into the teams you work with. You lead activities with focus on meeting business goals by driving quality improvements, proactively addressing risk, and staying at the forefront of trends and new developments in diagnostics. Your experience with Point of Care & Molecular devices will bring value as you work cross-functi...
As a. QC Technician II. you will quality testing and stability studies for raw materials, in-process, and finished products. All testing will be completed to support operations schedule and reviewed for accuracy and interpretation. Additionally, you will create and revise procedures through a documented quality system. Who are you. You are a detail-oriented individual with previous manufacturing experience and knowledge of general lab equipment. ...
Manager, R&D. Would you like to join a cutting-edge firm in the life sciences field. SEKISUI Diagnostics is looking for a Manager, R&D to join our MDx team. What you’ll do. As Manager, R&D you will build out and lead a team focused on product development for novel, point of care, molecular diagnostics devices that help further our company’s mission of providing intelligent solutions to enhance life through science and improve the health of all pe...
Manager, R&D. Would you like to join a cutting-edge firm in the life sciences field. SEKISUI Diagnostics is looking for a Manager, R&D to join our MDx team. What you’ll do. As Manager, R&D you will build out and lead a team focused on product development for novel, point of care, molecular diagnostics devices that help further our company’s mission of providing intelligent solutions to enhance life through science and improve the health of all pe...
As a member of the Production team, you will perform processes in accordance with Standard Operating Procedures. In this role, you will buffer preparations, lyophilization, purifications, and formulations. You will also operate, set up, perform adjustments, and minor troubleshooting on basic and complex production equipment. Maintaining proper record documentation and updates the Enterprise Resource Planning system as required. To succeed in this...
At SEKISUI Diagnostics, a leader in in vitro diagnostics, we help improve patient outcomes by doing what we've always done – focusing on innovating and developing highly accurate diagnostics tests, reagents and systems. As a Director, Quality Assurance you will play a critical role in our mission by creating targeted content that reaches health care providers to show case how our products can improve the lives of their patients. . Who are you. . ...
