Senior Engineer I, Quality

Elkton, MD
Jan 18, 2022
Jan 29, 2022
Engineer, IT, QA Engineer
Full Time
At Terumo Cardiovascular, we develop, manufacture and distribute medical devices for cardiac and vascular surgery with an emphasis on cardiopulmonary bypass, intra-operative monitoring and vascular grafting. This includes a full-line of perfusion products, endoscopic vessel harvesting products and surgical stabilization products. Our mission is to work as a team to save one more life, today and every day. We do this by providing lifesaving technology to cardiac surgery teams around the world.This position is responsible for investigating, planning, and implementing complex improvements in and/or additions to current products and manufacturing processes that directly affect safety, quality, regulatory compliance, and productivity. Involved with supporting projects requiring engineering team effort or a multi-discipline team effort. Working knowledge of medical device design controls and risk management per ISO 14971 preferred.1. In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. 2. Provide quality engineering expertise and leadership required to plan and implement specified projects to be completed including organizing and leading projects of various departments, planning and scheduling, coordinating resources (personnel, materials, time, money, suppliers), preparing proper documentation, etc.3. Lead cause-identification and problem-resolution for various types of quality, production or service-related issues.4. Monitor and control quality processes, identify issues and ensure they are resolved.5. Provide guidance in the design, fabrication, development, installation, validation, and qualification of equipment / processes which may include feasibility studies and/or proper documentation for justification of project and training.6. Plan and implementation of quality related projects to develop, install, and qualify new processes for manufacturing new products or improving existing processes.7. Plan work schedules, expenditures, attend meetings, and prepare monthly reports as required.8. Assign, delegate, and assist in the completion of engineering tasks or projects to other engineers in the department.9. Perform other duties as assigned.Qualifications Requires a four-year college degree in an engineering, scientific, or technical discipline with a minimum of six years of experience in a Quality Engineering or Process Engineering role in a regulated environment or a Master's degree with a minimum of five years of experience. In lieu of a four year degree, a high school diploma or equivalent and eleven years of quality engineering experience in a regulated manufacturing environment. Intermediate computer software skills, ie Microsoft Office. Industry recognized certification (eg CQE, CQA, PE) preferred.Terumo Cardiovascular is an equal opportunity employer. We promote recognition and respect for individual and cultural differences, and we work to make our employees feel valued and appreciated, whatever their race, gender, sex, sexual orientation, gender identity and/or expression, and genetic information.EOE Minorities/Women/Disabled/Veterans