Quality Engineer

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.
We have an exciting opportunity for a Quality Engineer. The person will support in closing Quality Records with the Logistics and Distribution Subject Matter Expert (SME's).
MAJOR RESPONSIBILITIES: Possesses and applies a broad and increasing knowledge of Quality to the completion of moderately complex assignments.
Identifies problems and possible solutions and takes appropriate action to resolve. 
In regard to Corrective and Preventative Action (CAPA) process the Quality Engineer will assist the team to ensure compliance to applicable standards.
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.
Assist or Perform gap assessment and Implement Corporate Policy requirements under the Quality system 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.
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.
3+ years' experience in a medical device company in a quality or regulatory function
Demonstrated experience with applicable regulatory standards and requirements
Ability to apply statistical tools in complaint trend analysis and utilize data analysis methodologies
Highly numerate with an aptitude for analysis.
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Operations Quality 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 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.
We have an exciting opportunity for a Quality Engineer. The person will support in closing Quality Records with the Logistics and Distribution Subject Matter Expert (SME's).
MAJOR RESPONSIBILITIES: Possesses and applies a broad and increasing knowledge of Quality to the completion of moderately complex assignments.
Identifies problems and possible solutions and takes appropriate action to resolve. 
In regard to Corrective and Preventative Action (CAPA) process the Quality Engineer will assist the team to ensure compliance to applicable standards.
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.
Assist or Perform gap assessment and Implement Corporate Policy requirements under the Quality system 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.
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.
3+ years' experience in a medical device company in a quality or regulatory function
Demonstrated experience with applicable regulatory standards and requirements
Ability to apply statistical tools in complaint trend analysis and utilize data analysis methodologies
Strong communication skills (written & verbal across cultures)
Highly numerate with an aptitude for analysis.
C onnect 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 .
The base pay for this position is
N/A In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Operations QualityDIVISION:RMDx Rapid and Molecular DiagnosticsLOCATION:Ireland > Galway : Parkmore East Business ParkADDITIONAL LOCATIONS:WORK SHIFT:Ie - 37.5Hst0 (Ireland)TRAVEL:Not specifiedMEDICAL SURVEILLANCE:NoSIGNIFICANT WORK ACTIVITIES:Not Applicable
Abbott  is about the power of health. For more than 135 years, Abbott  has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it's next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.
The people of  Abbott  come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life's greatest health challenges.
We invite you to explore opportunities at  Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer,  Abbott  welcomes and encourages diversity in our workforce.

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