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Sr. Engineer, Supplier Development Quality

Company: ICONMA
Location: Minneapolis
Posted on: November 22, 2021

Job Description:

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 suppliers.
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.

Job Requirements:
Required:
BS/MS degree in engineering, life sciences or related science degree.
5 yrs. experience required or 3 yrs. experience with MS degree.
Should have experience working with 3rd party or contract manufacturers.
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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