Endologix, Inc

  • Principal Software Quality Engineer

    Job ID
    2018-1962
    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.

     

    Responsible for leading and executing the Software Quality Engineering/Validation program, and supporting cross-functional departments to provide the organization with compliant computer systems that support business requirements and processes globally.

    Responsibilities

    • Develop, maintain, and improve software validation processes and procedures to assure compliance with worldwide regulatory requirements.
    • Lead software validation planning, development and execution activities.
    • Assuring all GxP computerized systems have been validated to reflect Endologix intended usage of the system.
    • Assurance that all other computerized systems have been validated per appropriate Endologix procedures and processes.
    • Partnering with IT to assure all Endologix systems have been identified, assessed and controlled for intended company use.
    • Evaluates new systems or changes to current systems to determine risk and validation impact.
    • Train other functions completing software validation on the regulations and procedures related to software validation.
    • Develop test scripts to validation Endologix software systems.
    • In conjunction with IT management, evaluate and determine strategic plan for implementing computer systems globally following the GAMP5 SDLC approach.
    • Manage, administrate, and configure quality system software

    Qualifications

    • 12+ years with a Bachelor’s degree, 8 years with a Master’s degree, 5 years with a PhD, of directly relevant experience
    • Experience in software validation within a regulated environment is required.
    •  Strong time management skills, good documentation practices and communication skills are required.
    • Direct and matrixed supervisory experience, strategic thinking and problem solving capability is preferred
    • Thorough understanding of FDA and ISO regulations and software metrics.
    • Ability to interpret regulations and guidelines governing medical devices including but not limited to, QSR’s, ISO 13485, ISO 14971, JPAL, CMDR, ANVISA and MDD.
    • Self-starter and works independently with minimum supervision

    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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