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QA Professional CAPA

Company: Abbott Laboratories
Location: Irving
Posted on: May 13, 2022

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 113,000 colleagues serve people in more than 160 countries. 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 113,000 colleagues serve people in more than 160 countries.We are a global medical device company with interfaces around the world. We have one consolidated CAPA group on site that does both process and product investigations for all areas. CAPA Investigations are performed commensurate with risk and we utilize risk management tools to make risk-based decision as to the depth of investigations that are performed. During our CAPA investigations, the use of DMAIC tools are used to evaluate and determine root cause and take appropriate corrective and preventive actions to prevent recurrence of the event.The CAPA group includes individuals who are project managers, engineers, medical technologists, technical writers and multi-taskers with a multitude of technical and quality system process knowledge across all areas from R launch of products, to on market support of product, to FDA regulations and quality system monitoring to demonstrate effectiveness of the CAPAs that are established. We use an electronic quality management system and facilitate cross functional team meetings to determine approach and document from a quality perspective the quality technical record. We interface with multiple areas which include supplier quality, product quality, engineering and manufacturing.WHAT YOU'LL DO:Conduct quality-related activities to deliver consistent, high quality documents, services, products and processes, which adds value to the business.Main ResponsibilitiesGeneral - Contributes to defining and timely achievement of overall project goals.Provides compliant solutions to a variety of problems of moderate scope and complexity.Interacts constructively with employees, managers and cross-functional peers.May lead a project with a limited scope, but usually a contributor on broader projects.Provides guidance to other Professionals and Technicians.Scope typically limited to one specific QA function.Quality System Compliance -Maintains awareness of standards that regulate our industry.Ensures compliance to site level policies and procedures by promptly reporting non-compliance issues to management within Division and Corporation as appropriate.Maintains vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management.Risk Management - Applies basic Risk Management principles to work. Participates in the development or modification of Risk management files. Provides compliant solutions to a variety of complex problems.Ensures compliant documentation related to area of responsibility.Design Control / Documentation & Change Control - Identifies areas for process improvement.Provides supporting information for change including reasons and justifications.Quality Engineering - Coordinates quality decisions between different quality and engineering groups.Participates in the development or modification of validation packages, design plans, and risk management deliverables (e.g. FMEAs). Team member helping and interfacing with suppliers to deliver product meeting our quality requirements. AccountabilityReceives general direction and exercises considerable discretion to own work detail.Recommends possible solutions. Ensures compliant documentation, carrying out tasks related to area of responsibility with management oversight.Decisions may have short and long term impact.REQUIREMENTSBachelor's degree in Life Science, Engineering, or closely related discipline is required OR relevant combination of education or experience. Minimum 2 years' work experience in Quality or related field experience; Less experience may be appropriate with advanced degree.Preferred Qualifications3+ years work experience in Quality in a regulated industryExperience with utilization of quality tools to solve problemsCross-functional team management experienceDemonstrates understanding of how their function supports the business.Demonstrates technical and business competencies that drive results and continuous improvement.WHAT WE OFFER At Abbott, you can have a good job that can grow into a great career. We offer:Training and career development, with onboarding programs for new employees and tuition assistanceFinancial security through competitive compensation, incentives and retirement plansHealth care and well-being programs including medical, dental, vision, wellness and occupational health programsPaid time off401(k) retirement savings with a generous company matchThe stability of a company with a record of strong financial performance and history of being actively involved in local communitiesLearn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.comFollow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.JOB FAMILY:Operations Quality DIVISION:ATM Transfusion LOCATION:United States > Irving : LC-02 ADDITIONAL LOCATIONS:WORK SHIFT:Standard TRAVEL:Yes, 5 % of the Time MEDICAL SURVEILLANCE:No SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Keywords: Abbott Laboratories, Irving , QA Professional CAPA, Other , Irving, Texas

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