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Quality Engineer

Company: Medartis, Inc.
Location: Warsaw
Posted on: January 24, 2023

Job Description:

PURPOSE: Contributes to the project teams by reviewing prints, risk assessments and quality planning. This includes communication with Engineering on inspection methods, materials and suppliers. - - - - - - - - - - - GENERAL RESPONSIBILITIES:

  • Follow and assure that personnel comply with FDA Quality Systems Regulation, ISO Standards and SOP's as defined by Nextremity's policies, practices and procedures.
  • Independently inspect components and finished goods for compliance to specifications.
  • Apply quality-engineering techniques on new and/ or existing products. - Assure all products meet or exceed customer requirements.
  • Work with suppliers to resolve non conforming issues or other matters related to supplier corrective actions, material review board and/or CAPAs.
  • Ensure that all record keeping and documentation is completed in a timely manner according to established policies, practices and procedures.
  • Continuously review methods, procedures, processes, etc. to determine improvements related to quality and cost to increase efficiencies. - Make recommendations and, upon approval, implement. - Motivate subordinates to recommend improvements.
  • Review changes to products in production for reliability impact to aid in the correction process, design or material problems.
  • Working knowledge in spreadsheets, databases and word processing software programs.
  • Authorized to represent the Quality Department in signing off on Change Orders.
  • Maintain effective working relations, communications and feedback with all other departments.
  • Perform other duties as required. SKILL AND EDUCATION REQUIREMENTS:
    • 3-5 years' experience in Quality Engineering or Supplier Quality.
    • BS in Engineering or related field or equivalent in experience and training.
    • In depth knowledge of quality system and ISO requirements --- - - Knowledge of basic statistical and engineering principals is essential.

Keywords: Medartis, Inc., South Bend , Quality Engineer, Engineering , Warsaw, Indiana

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