Endologix, Inc

  • Sr. Quality Operations Engineer

    Job ID
    2018-1815
    Location
    US-CA-Santa Rosa
    Category
    Quality
  • Overview

     

    Endologix develops and manufactures minimally invasive treatments for aortic disorders. We offer a dynamic, growth environment, competitive compensation and benefits, and a challenging, fulfilling experience in a fast-paced, growing company. Medical device professionals have the opportunity to develop and further their careers in a dynamic company that features the latest innovations in endovascular aneurysm repair and sealing.

     

     

    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.
    • 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

    QUALIFICATIONS

     

    Minimum Education:

     

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

     

    Minimum 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)

     

    Specific Skills, Knowledge & Behaviors

     

    (To perform the job successfully, an individual should demonstrate the following competencies):

     

    Core Competencies:

    ·         Customer Focus: Solicit and apply feedback from internal and external customers; Understand customers’ current and future expectations; Respond promptly to customer needs.

    ·         Innovation: Develop and champion unique ideas and solutions; Find new ways to use technology more effectively; Promote continuous learning.

    ·         Interdependent Partnering: Contribute to a productive and cooperative atmosphere; Show commitment to team objectives; Contribute own fair share of effort.

    ·         Master Complexity: Competently handle day-to-day work challenges; Thrive in uncertain circumstances; Adapt to changes in the work environment; Manage multiple tasks and competing demands; Change approach or method to best fit the situation.

    ·         Organizational & People Development: Function as both team player and leader; Provide informal feedback; Challenge the status quo; Strive for continuous professional development; Recognize the contributions of others; Set and achieve challenging goals.

    ·         Spoken Communication: Speak clearly and concisely; Listen carefully and seek clarification; Deliver effective presentations.

    ·         Written Communication: Write clearly and informatively; Create documents that are complete and accurate.

    ·         Commitment: Strive to attain quality results on time; Convey a sense of urgency and drive issues to closure; Earn a reputation for reliability and dependability.

    ·         Decisions: Make timely and sound decisions; Take risks and manage them intelligently.

    ·         Problem Solving: Proactively seek solutions; Gather and analyze information systematically; Develop alternative solutions; Think analytically and act decisively.

    ·         Diversity: Respond with sensitivity to people of diverse perspectives, ideas, backgrounds, lifestyles and ages; Foster open communication and respect for the individual.

     

     

    Supervisor Core Competencies:

    ·         Customer Focus: Solicit and apply feedback from internal and external customers; Understand customers’ current and future expectations; Respond promptly to customer needs.

    ·         Innovation: Develop and champion unique ideas and solutions; Find new ways to use technology more effectively; Promote continuous learning.

    ·         Interdependent Partnering: Contribute to a productive and cooperative atmosphere; Show commitment to team objectives; Contribute own fair share of effort.

    ·         Master Complexity: Competently handle day-to-day work challenges; Thrive in uncertain circumstances; Adapt to changes in the work environment; Manage multiple tasks and competing demands; Change approach or method to best fit the situation.

    ·         Organizational & People Development: Challenge and motivate people to reach their highest potential; Create an environment that encourages risk-taking; Set clear performance standards and hold people accountable for results; Value, recognize and reward the achievement of others; Promote teamwork; Encourage others to pursue challenging goals and to challenge the status quo; Foster continuous professional development and career growth of a diverse workforce; Provide challenging work assignments and development opportunities; Identify and champion high potential talent as a company resource; Coach and mentor future leaders; Require people to expand their capabilities, knowledge and skills; Function as both team player and leader; Provide frequent, informal feedback; Recognize the contributions of others; Continuously strive to increase and refine supervisory skills; Set and achieve challenging goals;

    ·         Spoken Communication: Speak clearly and concisely; Listen carefully and seek clarification; Deliver effective presentations.

    ·         Written Communication: Write clearly and informatively; Create documents that are complete and accurate.

    ·         Commitment: Strive to attain quality results on time; Convey a sense of urgency and drive issues to closure; Earn a reputation for reliability and dependability.

    ·         Decisions: Make timely and sound decisions; Take risks and manage them intelligently.

    ·         Problem Solving: Proactively seek solutions; Gather and analyze information systematically; Develop alternative solutions; Think analytically and act decisively.

    ·         Diversity: Respond with sensitivity to people of diverse perspectives, ideas, backgrounds, lifestyles and ages; Foster open communication and respect for the individual.

     

    Equipment Use & Abilities Required:

     

    ·         Equipment Use:  Copy machines, fax machines, calculators and personal computers and computer terminals.

    ·         Computer Skills:  Software proficiency in Microsoft Office Suite.

    ·         Language Skills:  Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, legal documents or governmental regulations.  Ability to write reports, business correspondence, and procedure manuals.  Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. 

    ·         Mathematical Skills: Ability to work with mathematical concepts such as probability and statistical inference.  Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. 

    ·         Reasoning Ability: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form 

     

    WORK ENVIRONMENT & PHYSICAL DEMANDS OF THE JOB:

     

    The noise level in the work environment is usually quiet. While performing the duties of this job, the employee is regularly required to sit; use hands and fingers; talk or hear. The employee is occasionally required to reach with hands and arms and to move within and between the buildings.  A computer terminal is used to access, input, and retrieve data. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision.

     

     

    Endologix, Inc. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected 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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