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 109,000 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 to support diagnostic testing which provides important information for the treatment and management of diseases and other conditions. IDEM is an over a billion-dollar business unit that now support significate growth for Abbott in COVID-19 related products in over 70+ countries.

　　PURPOSE OF THE JOB:

　　We have an exciting opportunity for a Senior Supply Chain Quality Engineer. The person will act as the EU Logistics and Distribution Subject Matter Expert (SME) for quality systems and/or subsystems and/or division processes. The successful person will be the team’s Process Owner for quality system processes. The Supply Chain Quality Engineer will be responsible for ensuring compliance and continuous improvements for business processes relating to the Quality Management System.

　　MAJOR RESPONSIBILITIES

　　Possesses and applies a broad and increasing knowledge of Quality to the completion of moderately complex assignments.

　　Applies problem-solving skills in order to deal creatively with complex situations, work that typically requires processing and interpreting, more complex, less clearly-defined issues. Identifies problems and possible solutions and takes appropriate action to resolve. Demonstrates skill in data analysis techniques by resolving missing/ incomplete information.

　　In regard to Corrective and Preventative Action (CAPA) process the Quality Engineer will assist the team to ensure compliance to applicable standards. Write and maintain EU Logistics and Distribution SOPs, provide training, develop and generate relevant metrics and trending.

　　For the Quality Incident process also ensure compliance to applicable standards. Write and maintain the Logistics teams SOPs, provide training, develop and generate relevant metrics and trending.

　　For any Logistics Internal and External Audits will be responsible to lead or Assist audit support activities., plus assist team on any validations, and other studies for technical content, statistical rationale, risk and clarity.

　　Perform gap assessment and Implement Corporate Policy requirements under the Quality system of the Distribution Centres. Perform risk assessment for critical processes of the Distribution Centres.

　　Identify and mitigate any supply Chain quality risks plus provide quality input to current processes and facilitate Quality Improvement initiatives.

　　In addition is involved with the Logistics Distribution team within the Abbott Document Control system support the writing of new Quality System documents or maintenance of existing documents, processing document change requests and coordinating the approval of SOPs, Work Instructions and Forms.

　　Provide Logistics supplier audit metrics which may be used in support of Management Review.

　　Develop and maintain data analytic tools to be used by the EU Distribution and Logistics. Expected to source complex data, program, with coding of data, apply statistics to analyse specific data sets, use Business Intelligence (BI) and related tools to prepare and communicate data, collaboration with business to understand data needs

　　Document and execute validation protocols needed to ensure Quality System and Regulatory compliance at the Distribution Centres or other sites as needed.

　　Support the environmental validations in the Distributions Centres as needed.

　　Perform and support internal, Abbott site and supplier audits as required.

　　All duties to be completed in compliance with established business policies.

　　EDUCATION & COMPETENCIES:

　　Bachelor's degree in Engineering, Chemistry, Biotechnology, Life Science or related technical field or equivalent experience and education.

　　4+ years’ experience in a medical device company in a quality or regulatory function

　　Demonstrated experience in Data Analytics and Quality Statistics Analysis

　　Demonstrated experience with applicable regulatory standards and requirements

　　Ability to travel 20% of the time

　　Must be proficient in Excel / SQL, at least one data visualization tool (Tableau, PowerBI, Qlikview)

　　Ability to apply statistical tools in complaint trend analysis and utilize data analysis methodologies

　　To facilitate the interaction with sites on different time zones, occasional out of hours working required.

　　Excellent communication skills (written & verbal across cultures)

　　Highly numerate with an aptitude for analysis.

　　Ability to lead meetings (by phone, video conference and face to face) to drive results and build relationships.

　　Connect with us at www.abbott.com or https://www.ie.abbott/ , on LinkedIn at www.linkedin.com/company/abbott-/ , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews (https://twitter.com/AbbottNews) .

　　An Equal Opportunity Employer

　　Abbot welcomes and encourages diversity in our workforce.

　　We provide reasonable accommodation to qualified individuals with disabilities.

　　To request accommodation, please call 224-667-4913 or email [email protected]