Engineer II, Quality
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 providing quality engineering support to operations and product development engineering to investigate, plan, and implementing product quality improvements in and/or additions to current products and manufacturing processes that directly affect safety, quality, regulatory compliance, and/or productivity
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 technical assistance 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. Provide quality engineering input 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.
5. Plan and implementation of quality related projects to develop, install, and qualify new processes for manufacturing new products or improving existing processes.
6. May assist in maintaining plant-wide calibration system and drawing control/document control system.
7. Gather, track, and analyze production data for meetings, business plan, etc. (yields/output/efficiencies).
8. Plan work schedules, expenditures, attend meetings, and prepare monthly reports as required.
9. Perform other duties as assigned.
Requires a four-year college degree in an engineering, scientific, or technical discipline with a minimum of three years of experience in a Quality Engineering or Process Engineering role in a regulated environment or a Master’s degree with a minimum of two years of experience. In lieu of a four year degree, a high school diploma or equivalent and a minimum of nine years of quality engineering experience in a regulated manufacturing environment. Basic computer software skills, i.e. Microsoft Office. Experience in medical device or pharmaceutical industry 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.