Quality Engineer

New Yesterday

Title: Quality Engineer II
Apply below after reading through all the details and supporting information regarding this job opportunity.
Location: Maple Grove, MN
Duration: 6-month position- Possible temp to hire for right individual, and if budget allows.
Job Description: 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. Assess potential new suppliers for technical, quality and manufacturing capabilities. Provides technical support for the introduction of components from a new supplier. Generates and maintains incoming inspection procedures. Trains inspectors to these procedures. Develops and/or sources inspection tools and equipment. Assists in generating component specifications. Generate test protocols, monitor testing, issue qualification test reports and approve components for use in products. Provide input to Design Engineering on new component technology and assist in component selection with quality and reliability analysis. Analyses 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 plans where necessary. May supervise inspectors. Quality System Requirements--In all actions, it demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
Required Qualifications: BS degree in engineering or technical field with minimum of 2 years of relevant experience. Experience in medical device, automotive, aeronautical, semiconductor, or other regulated industry. Project management: ability to influence cross functional global teams spanning Quality, Operations, R&D, and Sourcing. Experience in process validation, design controls, risk management, CAPA, SCAR. Ability to rapidly learn and use new software applications (e.g., PLM, ERP). Domestic and international travel up to 25%.
Preferred Qualifications: 3+ years of medical device engineering experience preferred. Medical Device Industry experience Problem Solving and Project Management experience Leadership experience on a materials or service commodity team. Lead auditor of quality systems experience (ISO 13485 or similar). ASQ certification (CQE, CBA, SSGB, SSBB) desired.
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Location:
Maple Grove, MN
Category:
Healthcare And Medical

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