Quality Engineer III — Medical Device (Onsite — Arden Hills, MN) Possible Temp-to-Hire

Our F500 Medical Device client has an exciting opportunity for a Quality Engineer III.

Job Summary: 

This Quality Engineer III on the Field CAPA and Design Quality team will lead cross functional teams to determine actionable root cause and implement effective solutions for high visibility issues impacting Active Implantable & Accessories product performance within the Cardiac Rhythm Management and Diagnostics ( CRMDx ) division .  This role is for a strong technical individual, with an innate technical curiosity, who is seeking leadership, complex problem-solving, and project management experience .  This individual will collaborate and partner with Research & Development, Regulatory, Marketing, Medical Safety, Manufacturing, Post Market, and other Quality organizations to achieve optimal results. They will also support other Design Quality work and projects as required in the areas of risk management, new product development, and sustainment.

Responsibilities will include:

• Leads cross-functional teams on complex product performance investigations, where suspected root cause is product design. Includes Nonconforming Events and Preventions (NCEPs), Corrective and Preventive Actions (CAPAs), and Field Action recommendations if applicable.

• Leads collaborative problem solving of complex technical issues using disciplined, methodical techniques. Tools used include DMAIC, Root Cause Analysis, 5 Whys, Cause & Effect Diagram, and Is-Is Not.

• Creates, maintains , and enhances cross-functional team partnerships. Provides guidance regarding technical strategies and approaches; works cross-functionally and across multiple sites in identifying and resolving technical issues .  Represents the team at key global and divisional leadership forums.

• Creates and mai ntains de tailed investigation documentation following Good Documentation Practice guidelines.

• Creates, reviews, and approves Quality System records for NCEPs and CAPAs.

• Presents updates in formal and informal reviews with all levels of the organization including high senior leadership.

• Mentors and guides other cross-functional teams and engineers by providing technical guidance and consulting on execution of NCEPs and CAPAs.  May include consulting across other divisions.

• Focuses on continuous improvement by championing and fostering the execution of projects within the local and divisional Design Assurance organizations.

• Fosters a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives .

• Monitors and ensures compliance with company policies and procedures.

• Demonstrates a primary