Senior Quality Engineer

Medical Device Industry.

Performs Quality Engineering functions in support of projects associated to product development/change including: design verification (design for six sigma), reliability engineering, component specification / approval, process evaluation and nonconforming product analysis in a project team environment. 

Ensure that component and finished devices are properly specified and inspected, and the associated manufacturing processes are properly designed, analyzed and validated. 

Evaluate component and sub-assembly subcontractors to ensure device quality and conformance to standards and regulations. Perform failure analysis to prevent or correct component and product failures as well as other risk management activities. Manage QA extended teams to ensure adequate support for all projects. 

Oversee and provide leadership for Quality Engineers, Associate Quality Engineers and other personnel as necessary. Tracking timelines and facilitating the required Quality Engineering Tools. 

Providing guidance to Divisional Quality Engineers and Associate Engineers with project and assuring proper and consistent implementation of the quality engineering tools. 

Provide support to other quality groups to assure efficient completion of project requirements.

Experience: 

Minimum 7 years' experience in design, manufacturing, or quality engineering position (medical device experience preferred). Three years of experience can be substituted for an advanced degree in related discipline. 

Experience with analytical tools and methods, including statistics (minitab preferred), DOE, and the use of computer software packages related to design, development and manufacturing. Statistical Quality control/statistical process control, design of experiments, failure mode and effects analysis. Experience in a regulated environment.

Education: 

BS degree in Engineering, Math Physical Science

All your information will be kept confidential according to EEO guidelines.