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Associate Director, Quality at Illumina, Inc.

Posted in General Business 30+ days ago.

This job brought to you by eQuest

Type: Part-Time
Location: San Diego, California





Job Description:

Responsibilities:


  • Lead a team of dedicated Quality Professionals for document control, configuration management, material master data and change management

  • Lead Business Process for ECM

  • Mentor team and site leaders to use practical problem solving to drive constant improvements in quality, productivity and cost

  • Manage a cross functional program for document control, configuration management, material master data and change management

  • Provide training of company employees on the principles of document control, configuration management, material master data and change management

  • Drive continuous improvement projects to advance processes and capabilities

  • Support policy deployment activities to define quality strategic objectives and metrics across the organization

  • Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices

  • Coordinate the corporate document control, configuration management, material master data and change management

  • Establish procedures and integrated program plans for achieving and maintaining the required level of product quality in preparation for FDA, ISO and third-party audits

  • Builds effective, cross-functional teams that accomplish project objectives on a prescribed schedule and with a prescribed budget

  • Work with business process owners to identify and implement solutions to improve document control, configuration management, material master data and change management

  • Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices

  • Provide subject matter expertise during internal and external quality system audits

  • Represent functional area in Management Review and Quality Review processes

  • Provide management with plans and status updates on assigned responsibilities and goals and escalate issues in a timely fashion

  • Participates in the definition of area goals and drives teams to deliver on goals

Requirements:


  • 10+ years of experience at a manager level or above

  • Experience in document control, configuration management, material master data and change management

  • Experience in quality management in a regulated environment (FDA, ISO13485);

  • Continuous improvement leadership experience applying the elements of lean/operational excellence

  • Knowledgeable of Federal and other regulations, e.g. QSRs, ISO, ISO 13485, CMDR

  • Previous management or project experience is required

Experience/Education:


  • Preference for managing PLM function and experience with Siemens Teamcenter

  • Overall knowledge of most areas within ECM

  • Typically has depth of technical knowledge in ECM derived from experience in non-management and middle management roles.

  • Requires Bachelor's degree or equivalent, may require an advanced degree (Master's), in applicable field or equivalent.

  • Typically has 7+ years of applicable management experience

  • Doc control experience/management

  • Change management

  • Configuration management

Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you have a disability or special need that requires accommodation, please contact us at applications@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf