Engineer I, Quality.

Job Summary

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.

Job Details/Responsibilities

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.

Qualifications/ Background Experiences

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.