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Quality Control/Assurance Representative

Company: Edwards Lifesciences
Location: Irvine
Posted on: August 21, 2019

Job Description:

Provide Quality Control metrics, sustaining support and document change support to Quality Assurance/Quality Control departments.
Job Functions:


  • Develop, review, revise and implement document changes. Support to ensure quality documents are up to date.
  • Monitor and assist to ensure commitments such as calibration, training, project activity are not passing their due dates.
  • Develop, generate and keep report, presentation, Quality control matrices up to date, prepare slides.
  • Assist supervisors, group leaders or leads to ensure all improvement/change activities are implemented within requirements and timelines.
  • Order supplies and other tasks as assigned by management.

    #LI-TR1
    #AS

    Education/Experience:
    H.S. Diploma or equivalent with 4 years of previous related experience in quality related functions required.
    Required Skills:


    • Proven expertise in MS Office Suite and ability to operate general office machinery.
    • Excellent written and verbal communication skills and interpersonal relationship skills.
    • Experience working in a medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment required.
    • Demonstrated problem-solving , critical thinking, and investigative skills Ability to build stable working internal/external relationships.
    • Full knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality compliance.
    • Good knowledge of Good Documentation Practices (GDP) as it relates to document updates/training.
    • Ability to manage confidential information with discretion
    • Attention to detail.
    • Ability to manage competing priorities in a fast paced environment.
    • Must be able to work in a team environment, including inter-departmental teams and representing the department on specific projects.
    • Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control.

Keywords: Edwards Lifesciences, Newport Beach , Quality Control/Assurance Representative, Other , Irvine, California

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