Endologix, Inc

  • Senior Quality Operations Engineer

    Job ID
    2018-1955
    Location
    US-CA-Santa Rosa
    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.

     

    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.
    • Completes investigations in a timely manner to ensure customer service levels are maintained.
    • Coordinates 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.
    • Instill a sense of urgency to ensure goals are met in a timely manner while meeting regulatory and quality standards and customer requirements.
    • Be self-directed with the ability to take initiative and be accountable for results, and demonstrate confidence, maturity and integrity.
    • Communicate effectively to all levels of an organization.
    • Ability to prioritize work activities to ensure critical priorities; those with highest impact on goals.
    • Protect Endologix confidential and proprietary information in accordance with Legal guidelines
    • Perform other duties as assigned by supervisor.

    Qualifications

    Experience:

    • Minimum of five (5) years’ experience in a regulated industry [Medical devices, Pharma, Aerospace, Automotive]
    • Minimum of three (3) years’ 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)

    Education:

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

    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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