Performs Quality Engineering functions in support of projects associated with 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. Track timelines and facilitate the required Quality Engineering Tools.
Provide guidance to Divisional Quality Engineers and Associate Engineers with projects and assure 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 a 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.
Qualifications
Education:
BS degree in Engineering, Math, or Physical Science.