Sr. Engineer, Supplier Development Quality
Posted on: November 22, 2021
To support EU-MDR project and 3rd party manufacturers.
Individual will be supporting 3rd party manufacturers regarding
complaints management, regulatory submissions etc.
Drives improvement and corrective action in the quality of
components sourced from outside suppliers. Provides technical
support in the selection of suppliers.
Develops acceptance criteria for materials. Monitors supplier
performance to drive supplier corrective action, manufacturing
yield issues and field failures. Responsible for compliance with
applicable Corporate and Divisional Policies and procedures.
Assess potential new suppliers for technical, quality and
manufacturing capabilities. Provides technical support for the
introduction of components from a new supplier.
Analyzes incoming material defects. Dispositions and drives
corrective action, as necessary. Communicates issues to
Reviews new design specifications and provides input from component
quality and manufacturability perspective.
Investigates field failures related to supplier materials. Develop
corrective action plan where necessary. Failure to adequately
perform tasks can result in noncompliance with governmental
regulations. May lead a project team of moderate scope. Provides
guidance to less experienced staff.
BS/MS degree in engineering, life sciences or related science
5 yrs. experience required or 3 yrs. experience with MS degree.
Should have experience working with 3rd party or contract
Med device exp, ISO 13485.
EU-MDR knowledge and experience.
As an equal opportunity employer, ICONMA prides itself on creating
an employment environment that supports and encourages the
abilities of all persons regardless of race, color, gender, age,
sexual orientation, citizenship, or disability.
Keywords: ICONMA, Minneapolis , Sr. Engineer, Supplier Development Quality, Engineering , Minneapolis, Minnesota
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