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Quality Engineer

Company: Mackenzie Stuart
Location: Stratford
Posted on: February 14, 2021

Job Description:

A successful candidate will be responsible for the development, implementation, maintenance, and improvement of quality assurance processes with a leading manufacturer within the Respiratory Device sector, and located within California.

  • Monitor and improve the quality of operational processes and outputs for the Respiratory Device department.
  • Support development of all medical devices, ensuring in line with ISO 13485 and, ISO 14971 regulations.
  • Ensure internal Design Control and Process Control policies and procedures are implemented on design and process change projects.
  • Provide guidance on the application of internal procedures, including Design Control and Process Control, to the development teams, within the framework of regulatory requirements.
  • Must carry out the following processes: Verification & Validation testing, Risk Analysis and Assessments, Design Assurance.
  • Collaborate with Operations to develop and implement controls and improvements.
  • Ensuring that workflows, processes, and products comply with safety regulations.
    • Bachelor of Science degree in Engineering or equivalent .
    • 3-5 years of experience required.
    • Ability to interpret mechanical drawings and electrical schematics.
    • Good verbal (including presentation) and written communication skills
    • Ability to effectively work on project teams

Keywords: Mackenzie Stuart, Visalia , Quality Engineer, Engineering , Stratford, California

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