Abbott Quality Systems Engineer in Cootehill, Ireland

Company Details:

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.

Job Description

  • Follow all Environmental, Health and Safety Rules and Regulations in the plant.

  • Report any current or potential hazards to your manager immediately.

  • Wear the correct Personal Protective Equipment (P.P.E.) at all times. Consult the appropriate SOP where required.

  • The Quality Systems Engineer will be part of the Engineering Team reporting to the Technical Engineering Manager.

  • Manage and co-ordinate the Engineering Drawing System, and all related documentation.

  • Represent the Engineering Department at the Validation Review Board, Responsible for ensuring all Engineering projects are compliant with Validation protocols.

  • Manage the plants calibration program.

  • Responsible for the tracking and timely closeout of all Engineering related exception reports on the Quality Management System.

  • Manage the training – curricula for Engineering department

  • Support the CAPA and Quality Metrics programme as required.

  • As part of the Food Safety Team, conduct compliance audits and walk-downs and complete necessary follow-up reports.

  • Participate in internal audits.

  • Support all areas of Engineering as required, participate in plant projects as required.

  • This Job function will change where update procedures to GMP, EHS, Technical / New Equipment, Quality Procedures & SOP’s are made.

  • This list of responsibilities may change depending on plant needs and employees are expected to be adaptable and flexible were this need arises.

Education Required

  • Bachelor’s Degree in Pharmaceutical Science, Food Science, Dairy Science or related Engineering qualifications. Food Microbiology or Food Chemistry would be desirable however, not essential. Knowledge

  • Knowledge of AutoCAD, and proficient in the drafting and editing of electronic based drawings.

  • It is an advantage to have knowledge on Validation and CAPA Policies or FDA regulations in relation to validation.

  • Food Engineering, thermal heat processing and fluid flow are advantageous.

  • Knowledge of Validation preferred.

  • Project Management Skills or experience with Project Management is essential.

  • Excellent interpersonal skills and very good computer literacy.

  • Ability to work as an effective member of a high performance team.

Accountability / Scope

  • This function will have the responsibility to provide direction, documentation, execution and review for plant validation activities.

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