Quality Engineer – CAPA job opportunity at Abbott.

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DateMore Than 30 Days Ago bot
Abbott Quality Engineer – CAPA
Experience: General
Pattern: full-time
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degreeGeneral
loacation United Kingdom-Dundee, United Kingdom
loacation United Kingdom..........United Kingdom

      JOB DESCRIPTION: About Abbott 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 110,000 colleagues serve people in more than 160 countries. Abbott serves the Irish market with a diverse range of healthcare products including diagnostics, medical devices and nutritionals products. In Ireland, Abbott employs over 4,000 people across nine sites. We have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations and shared services in Dublin and Galway. We have been operating in Ireland since 1946. Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies. Our in-vitro Diagnostic Assay manufacturing site in Dundee has an exciting opportunity for a Quality Engineer – CAPA to join the team. MAIN   P URPOSE OF JOB   This is an individual contributor role with expectations aligned to the Capabilities and Behaviours as set out in the Abbott Dundee Employee Handbook.     Working as part of the   Product Support Team , the   Coordinator,   CAPA   is primarily responsible for   providing ownership ,   oversight   and reporting   of   Nonconformance   and Corrective and Preventive Action (CAPA) processes at Abbott Dundee.     ACCOUNTABILITIES    Ownership of the   Nonconformance   and Corrective and Preventive Action (CAPA)   System.   Assist   in the initiation,   processing   and completion of QI/CAPA records in the electronic system.    ensuring   record   owners are assigned, and   timely   responses and approvals are provided in alignment with quality goals.   Assessing and documenting the impact of each Nonconformance event to   determine   the   requirement   and extent of investigation.   Lead meetings and communications for QI/CAPA updates, information, and concerns , including chairing site   CAPA   Review board.   Communicate confidently and effectively with all levels of management,   peers   and key stakeholders, including   timely   escalation of quality issues.   Responsible for collation of metrics and reporting on   regular   basis in accordance with established procedures.   Support team in the delivery and oversight of CAPA training program.   Provide support and subject matter   expertise   during audits and inspections.   Lead and/or contribute to continuous improvement initiatives and projects.   Taking a self-motivated approach to continuous professional development and engaging with site training initiatives.   Being aware of the policies as set out in the Abbott Employee Handbook and able to enact them as appropriate   Carries out other duties as and when requested by Line and or Department Manager     BASE   REQUIREMENTS   Degree or equivalent, preferably a life science subject area, and/or   Experience in a regulated industry preferred .   Experience with a range of root cause investigations tools and techniques.   Competence with QI/CAPA processes     BACKGROUND   A practical understanding of immunoassay and clinical chemistry testing, In-vitro Diagnostics (preferred)   Experience with an Enterprise Resource Planning System (ERP)   Experience with Electronic Document Management Systems (EDMS)   Experience with QI/CAPA Systems (Agile preferred)   Experience with Complain t   Investigation systems (Helix preferred)   Proficient with MS Word,   Excel   and Power-Point.          The base pay for this position is N/A In specific locations, the pay range may vary from the range posted.       JOB FAMILY: Operations Quality       DIVISION: CMI ARDx Cardiometabolic and Informatics          LOCATION: United Kingdom > Dundee : 17 Luna Place       ADDITIONAL LOCATIONS:       WORK SHIFT: Standard       TRAVEL: No       MEDICAL SURVEILLANCE: Not Applicable       SIGNIFICANT WORK ACTIVITIES: Not Applicable                  

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