Abbott Operations Quality Engineer in Donegal Town, Ireland
Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150+ countries and employs approximately 97,000 people.
In Ireland, Abbott has five business units, represented across eight manufacturing sites. The Abbott Diabetes Care division based in Donegal Town manufactures FreeStyle blood glucose test strips for use in diabetes management. Among Abbott Diabetes Care leading brands are the FreeStyle Precision, FreeStyle Lite and FreeStyle Libre system.
Visit Abbott at www.abbott.ie at http://www.abbott.ie/ or www.abbott.com at http://www.abbott.com/ and connect with us on Twitter at @AbbottNews.
The Operations Quality Engineer is responsible for implementing and maintaining the effectiveness of the manufacturing operations quality systems, ensuring the site delivers safe and effective products that meet customer needs whilst maintaining compliance
Manage functional area’s compliance to site and divisional policies and procedures.
Champion the continuous improvement and effective maintenance of the QMS
Subject Matter Expert in use of risk management tools to prioritise activities and justify the effort required
Accountable for building and maintaining successful cross functional relationships with departments such as R&D, Technical, Engineering, Operations and Regulatory Affairs in order to achieve all project goals
Manage own and the teams Health and Safety within the working environment; highlight opportunities for improvement to EHS performance
CORE JOB RESPONSIBILITIES:
Act as Subject Matter Expert for the monitoring and compliance of the Quality Management System as it applies to site Operations:
Act as Subject Matter Expert for the CAPA process by identifying and raising Quality / Compliance issues, reviewing Exception Reports (ERs) and confirming Corrections and Corrective Actions
Make Quality / Compliance decisions on product during processing, manufacturing, testing, monitoring and packaging.
Manage audit readiness activities, plan, conduct and review focused audits, communicate findings and work with area leads to implement corrective actions in functional area
Support PQA and TPM activities, information gathering, Risk Assessments, product bracketing and information sharing.
Identify and manage projects to enhance and promote the effectiveness and efficiency of the quality system and product quality.
Champion a “right first time” approach to Quality Records by ensuring accountability for functional responsibilities.
POSITION ACCOUNTABILITY / SCOPE
Responsible for taking actions and making decisions that minimise the risk of patient harm or safety as it relates to the product being manufactured by ADC.
Responsible for ensuring that products, processes, equipment and software designed, changed or purchased by ADC meet the quality and regulatory standards.
The job holder must ensure all quality records associated with the role are well organised, clear and compliant.
Third level science / engineering or Manufacturing qualification
MINIMUM EXPERIENCE/TRAINING REQUIRED
Two years in a Manufacturing / Science or Engineering environment.
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 firstname.lastname@example.org