Quality Incident Analyst
Company: Abbott Laboratories
Posted on: November 22, 2021
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
- Conduct/ document in depth and effective failure investigations
and DHRs reviews including the implementation of corrective and
- 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
- 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
- Bachelor degree in Engineering or Science.
- 3+ years of experience in the QSR/ISO --- regulated medical
- Advance computer skills and use of software
- Thorough knowledge in QSR, ISO requirements. Knowledgeable in
statistics. Strong knowledge on failure mode analysis
- Proficient in the preparation of failure investigations,
technical reports and presentations.
- Excellent communication (oral and writing) and interpersonal
- Requires good networking and negotiation skills with varied
- 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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