Methode Electronics, Inc

  • Manufacturing Quality Engineer

    Division Dabir Surfaces
    Requisition ID
    2018-1702
    Category
    Engineering
    Location : Location
    US-IL-Harwood Heights
  • Overview

    Dabir, a division of Methode Electronics, is seeking a Quality Engineer to join our team in Harwood Heights IL.  In this role, you will plan and direct activities concerned with the development, application, and maintenance of quality standards for manufacturing processes, materials, and products under ISO13485 and FDA QSR compliant quality system.  This includes ensuring customer satisfaction, managing quality and process improvements, first article review, FMEA, 8-D analysis, Corrective Action, 5S, return analysis, and supplier qualification.  You will also create and approve work instructions, SOPs, quality plans and control plans. Additionally, you will execute test method validations and measure/evaluate supplier and production quality metrics.

     

    Dabir is a revolutionary healthcare company dedicated to developing breakthrough technologies. Using scientific-based clinical research and state-of-the-art medical manufacturing, our team of healthcare professionals and advanced innovative research and development colleagues is pioneering surface technologies to prevent and treat pressure injuries. We are committed to delivering excellence in patient care and improving patient outcomes.  To learn more about Dabir, visit www.dabir-surfaces.com.   

     

    Established in 2012, Dabir is a wholly owned subsidiary of Methode Electronics Inc. Methode (NYSE: MEI), since 1946, is a global, leading developer of custom-engineered electronic technologies, applications and solutions. Headquartered in Chicago, Illinois, Methode employs over 5,500 employees worldwide with 20 manufacturing, design, testing and customer support facilities spanning over 10 countries.  Methode provides total business solutions with unmatched customer focus, problem-solving and world-class manufacturing to a diverse group of customers in the automotive, industrial and medical markets.

    Responsibilities

    • Contribute to maintenance and compliance of the Quality Management System
    • Participate, as a member of the design team, in the stages of device design including addressing any open issues promptly
    • Develop risk management documentation as part of the product development process in accordance with ISO 14971
    • Participate in design and manufacturing reviews by reviewing part drawings to assign receiving inspection criteria and critical characteristics
    • Prepare and ensure quality plans and control plans conform to product, process, and line specifications
    • Develop and initiate standards/methods for inspecting, testing, and evaluating
    • Review test plans, and verification/validation protocols and reports for adherence to quality principles and Quality Management System requirements
    • Interface with customers, sales team, internal manufacturing, and suppliers on quality related issues, product returns, and complaint handling
    • Lead the problem solving activities for internal and external related quality issues
    • Address internal, external, and UL audits by working with the team on audit findings and following up with resolution for closure
    • Measure and evaluate process/production metrics, using statistical data to confirm compliance with standards and seek improvement opportunities
    • Uphold FDA Quality System Regulations (QSR) and ISO 13485 roles, responsibilities and authorities
    • Other duties as assigned

    Qualifications

    • Bachelor degree in Engineering or other technical discipline required
    • At least 5 years of Quality Engineering experience
    • Five years’ experience in a manufacturing environment  
    • Sound Knowledge of ISO 9001
    • Ability to read and interpret common scientific/technical information and engineering specifications and drawings
    • Experience with risk management documentation
    • Proficiency in using Microsoft Excel and Word required
    • Must be able to perform job functions independently with limited direction
    • Strong time management skills, integrity, and attention to detail
    • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
    • Ability to stand, sit, bend, stoop and have use of hands to feel and examine small parts
    • CQE, CQA, or Lead Internal Auditor, or Lean Manufacturing Certification preferred
    • Medical device experience with FDA QSR and ISO13485 quality system a plus 
    • 5% domestic travel

     

    Methode Electronics is an equal opportunity employer.  We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, genetic information and other legally protected characteristics. The EEO is the Law poster is available here: EEO Poster, if you need a reasonable accommodation because of a disability for any part of the employment process, please send an e-mail to recruiting@methode.com or call (708) 867-6777 and let us know the nature of your request and your contact information.

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