Endologix, Inc

  • Quality Operations Engineer

    Job ID
    2018-1960
    Location
    US-CA-Irvine
    Category
    Quality
  • Overview

    Endologix develops and manufactures the latest innovations in endovascular aneurysm repair and sealing. We are a fast-moving, high energy organization. Employees are offered development opportunities and new responsibilities that might have taken them significantly more time in other organizations. Our commitment is to promise the development and refinement of skills while providing competitive compensation and benefits.

     

     

    Job Scope and Purpose:

     

    Primary responsibilities will be to support, plan, manage, and execute the Quality Operations activities to support the manufacturing of various AAA devices. Plan and implement Quality Operations programs designed to ensure continuous production of products consistent with established standards by performing the duties listed below.

     

    Responsibilities

    • Assure that activities are in compliance with the respective areas that are applicable from FDA GMP/GLP, ISO 13485/8, CMDR, CMDCAS, Medical Device Directive, Japan (ordinance 210, GMP, GPMI, Pharmaceutical Affairs Law) and other national and international standards as necessary.
    • Provide quality engineering support. Address product related issues arising in the manufacturing clean rooms and assure elements such as NCR, CAPA, audits and scrap are being used properly.
    • Perform investigations to determine root cause. Assign and ensure completion of corrective and preventive actions.
    • Complete investigations in a timely manner to ensure customer service levels are maintained.
    • Coordinate the reporting and provides trend analysis for non-conformance incidences.
    • Partner with Manufacturing/Operations, R&D, supply chain and other functions to ensure quality assurance and engineering methods drive the highest quality products and processes from development through manufacturing in accordance with applicable requirements.
    • Lead implementation and infusion of quality engineering tools throughout the organization to drive methodical and process-based approaches to product and process development. Utilize same approach to existing products and processes, applying where possible, new technologies and methods.
    • Utilize quality toolbox including six sigma methodology, lean principles, advanced statistics, reliability engineering, design assurance techniques, and other proven tools.
    • Support sustaining and new product projects.
    • Support the manufacturing managers and supervisors in their efforts to ensure production needs are met.
    • Determine equipment qualification, process validation, and product line design/modifications requirements. Advise Manufacturing on installation and maintenance of inspection and testing procedures for raw materials, packaging materials, components and finished products.  Support design transfer activities.
    • Work with Manufacturing to provide feedback to production personnel regarding accuracy of assembly procedures. Work with Facilities to establish and maintain effective environmental monitoring systems.
    • Lead development of Risk Management documentation.
    • Assess in conducting and documenting process and system audits using specific regulations and company procedures as audit standards.
    • Promote and organize training activities related to product quality, cost, reliability, and regulatory compliance. Develop strategies to ensure continuous improvement in the ability to design and manufacturing quality products.
    • Maintain an up‑to‑date knowledge in the techniques of Quality Assurance/Quality Control and in the company products and process technologies.
    • Develop systems for the identification, analysis, correction, and prevention of quality issues.
    • Work with Quality and the Operations Team to develop a culture of accountability, empowerment, continuous improvement, customer focus, collaboration, and celebration of good work, involvement and development of all people within the team.
    • Protect Endologix confidential and proprietary information in accordance with Legal guidelines.
    • Perform other duties as assigned by supervisor
       

    Qualifications

    Minimum Education:

    • Bachelor of Chemical, Biomedical, Mechanical, Industrial, or Manufacturing Engineering (or related field)

    Minimum Experience:

     

    • Minimum of one year and six months experience in a regulated industry [Medical devices, Pharma, Aerospace, Automotive]
      • Minimum of one (1) year experience in a regulated industry [Medical devices, Pharma, Aerospace, Automotive] if individual has a Masters of Chemical, Biomedical, Mechanical, Industrial, or Manufacturing Engineering (or related field)

    Endologix, Inc. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity, gender expression, genetic information, marital status, veteran status or any other characteristic protected by applicable federal, state, or local law.

                                                

    If you are a qualified individual with a disability or a disabled veteran, you have the right to request an accommodation if you are unable or limited in your ability to use or access our career center as a result of your disability. To request an accommodation, contact a Human Resources Representative at Endologix Global Headquarters at 949-595-7200 or Endologix Santa Rosa Facility at 707-543-8800

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