Endologix, Inc

  • Supplier Quality Engineer

    Job ID
    2019-2034
    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 supporting the Supplier Quality program and supporting cross-functional departments to acquire highest quality materials from suppliers that meet the requirements while improving the cost of quality of parts, processes and products. Provides support in the development and maintenance of company’s Quality Systems.

    Responsibilities

    • Responsible for supporting supplier quality management program
    • Day to day activities include; supplier auditing, SCAR management, Supplier NCMR investigations, Supplier file maintenance, Supplier metrics, ASL and ACL
    • Resolve issues at the supplier impacting product quality.
    • Support in house manufacturing and customer complaint issues related to supplier parts.
    • Assist receiving inspection requirements as needed.
    • Participate in the supplier qualification, approval and selection process.
    • Team member on supplier related projects starting in new product development.
    • Perform other duties as assigned by supervisor.

    Qualifications

    Qualifications:

    • Self-starter and works independently with moderate supervision
    • Demonstrated understanding of and ability to interpret regulations and guidelines governing medical devices including QSR’s, ISO 9001, ISO 13485, ISO 14971, JPAL, CMDR, and MDD.
    • Demonstrated understanding of auditing principles.    
    • High level of competence in Quality including formal root cause analysis and managing deployment of corrective and preventive actions.                                                                                                             
    • Strong communication, detail, and organization skills required.
    • Good judgment skills within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
    • Flexibility to handle multiple tasks and meet timelines. Normally receives minimal instructions on routine work, general instructions on new assignments.
    • ASQ CQE or CQA preferred.

     

    Education:

    • BS in Engineering or related field

    Experience:

    ·  Minimum 0-4 years’ experience in the medical device industry is preferred

     

    Core Competencies:

    • Interpersonal Effectiveness: Actively seeks to understand perspectives and interpersonal needs and expectations of others at all levels, builds self-awareness, flexes personal style appropriately, and works through conflicts constructively and appropriately
    • Communication: Effectively uses all mediums of communication as appropriate, presents well to groups, actively listens, and continuously identifies opportunities to build communication skills
    • Collaboration & Teamwork: Actively works together with formal and informal team members to build relationships and achieve team goals
    • Prioritization: Effectively prioritizes work to ensure timely completion of work within scope
    • Global & Systems Thinking: Continuously seeks to learn about and embrace global nuances, works across functions and geographies, seeks to align with diverse groups, and seeks to understand interdependencies and impacts of actions across functions and the company
    • Technical Expertise: Continuously builds functional and technical expertise, and pro-actively applies that technical expertise in progressively broader scope
    • Continuous Improvement: Learns and uses best practices tools and methodologies to assess, identify, and executes on opportunities to improve; Focus on learning and building new capabilities into self
    • Problem Solving & Problem Prevention: Learns and uses strong problem-solving methodologies and tools, focuses on root cause analysis, and shows orientation towards problem prevention
    • Accountability: Focuses on results, takes initiative without direction, takes ownership for all work within scope, builds relationships and works across departments, functions, or areas of responsibility

     

    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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