Job Description

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.

About the Role

We have an exciting opportunity for a Quality Engineer to join our team in Ireland. As a Quality Engineer, you will play a key role in ensuring the quality of our products and processes.

Key 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.
• Assists the team to ensure compliance to applicable standards in regard to Corrective and Preventative Action (CAPA) process and Quality Incident process.
• Writes and maintains the Logistics teams SOPs, provides training, develops and generates relevant metrics and trending.
• Assists or performs gap assessment and implements Corporate Policy requirements under the Quality system of the Distribution Centres.
• Identifies and mitigates any supply Chain quality risks and provides quality input to current processes and facilitates Quality Improvement initiatives.
• Supports the Logistics Distribution team within the Abbott Document Control system, assisting with 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.
• Provides Logistics supplier audit metrics which may be used in support of Management Review.
• Documents and executes validation protocols needed to ensure Quality System and Regulatory compliance at the Distribution Centres or other sites as needed.
• Supports the environmental validations in the Distributions Centres as needed.
• Performs and supports internal, Abbott site and supplier audits as required.

Requirements

• 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.

About Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. For over 135 years, we have been helping people reach their potential by advancing innovative technologies in healthcare.

We invite you to explore opportunities at Abbott and 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.