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Quality Incident Analyst

Company: Abbott Laboratories
Location: Austin
Posted on: November 22, 2021

Job Description:

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.HAVE YOU EVER DREAM OF MAKING AN IMPACT ON THE WORLD?How? Become a Quality Incident Analyst at Abbott in Arecibo, Puerto Rico. As a Quality Incident Analyst you will be responsible to conduct NCMR---s, Complaints and CAPA investigations with the objective of identifying the root cause(s) analysis of the non-conformance situation being investigated. Provides technical guidance towards the identification of the causes for non-conformances and process--- failures, and for the implementation of the remedial, corrective and preventive actions thus assuring process performance and compliance against QSR, GMP, and ISO requirements for the entire Business Unit manufacturing process. HOW WILL YOU MAKE A DIFFERENCE?

  • Conduct/ document in depth and effective failure investigations and DHRs reviews including the implementation of corrective and preventive actions.
  • Provides guidance or assist other lead investigators to assure causes of non-conformance are identified, understood and that appropriate corrective/preventive actions are implemented including providing training on tools for process evaluation.
  • Reviews and analyses quality trends with the manufacturing/quality teams to recommend and implement appropriate corrective actions.----
  • Evaluate and implemented corrective and preventive actions against trends to assess effectiveness of the same.
  • Perform and maintain the failure investigation files and the trends preparation and presentation for management meetings.
  • Support compliance department activities such as: Quality audits, CAPAs, QDRs and readiness.
  • Understand work environment issues such as OSHA regulations, FDA Quality Systems regulations and ISO requirements.
  • Ensure compliance with all procedures and all applicable regulatory agency requirements.
  • Other duties as assigned. CAN---T WAIT TO GET STARTED?To be successful in this role, you will require the following qualifications:
    • Bachelor degree in Engineering or Science.
    • 3+ years of experience in the QSR/ISO --- regulated medical device operation.
    • Advance computer skills and use of software application(s).
    • Thorough knowledge in QSR, ISO requirements. Knowledgeable in statistics. Strong knowledge on failure mode analysis techniques.
    • Proficient in the preparation of failure investigations, technical reports and presentations.
    • Excellent communication (oral and writing) and interpersonal skills.
    • Requires good networking and negotiation skills with varied cultures.
    • Entails heavy interaction with technical peers and manufacturing associates, in operations in the mainland.
    • Must be fully bilingual Spanish/English.

Keywords: Abbott Laboratories, Austin , Quality Incident Analyst, Professions , Austin, Texas

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