Engineer I, Quality

Company: Terumo Medical Cooperation
Location: Ashland
Posted on: June 12, 2021

Job Description:

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. Assist in the implementation of specified projects to be completed including organizing and leading projects of various departments, planning and scheduling, coordinating resources (personnel, materials, time), preparing proper documentation, etc.

3. Participate in quality issues cause-identification and problem-resolution for various types of production or service-related issues.

4. Provide quality engineering input in the design, fabrication, development, installation, validation, and qualification of equipment/processes that may include feasibility studies.

5. Provide assistance for planning and implementation of projects to develop, install, and qualify new processes for manufacturing new products or improving existing products / processes.

6. Assist in review and approval of product and process change control documentation and specifications.

7. Gather, track, and analyze quality data for meetings and prepare monthly reports as required.

8. Plan own work schedule, 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 or a high school diploma or equivalent and a minimum of six years of quality engineering experience in a regulated manufacturing environment. Basic computer software skills, i.e. Microsoft Office.

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

Keywords: Terumo Medical Cooperation, Boston , Engineer I, Quality, Other , Ashland, Massachusetts