Operations Quality Engineer Shift

Abbott

Kilkenny

On-site

EUR 55,000 - 75,000

Full time

4 days ago

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Benefits offered by this job

Family health insurance

Excellent pension scheme

Life assurance

Career Development

Fantastic new facility

Growing business plus access to many:2

Job summary

Abbott in Kilkenny invites applications for an Operations Quality Engineer. The role analyses quality standards for components, materials or services and provides guidance to Manufacturing/Operations, Product Test and Incoming Materials to ensure quality and compliance for on-time, full delivery of products.

The position operates on a 4-cycle shift basis, requiring strong quality control and continuous improvement focus within a manufacturing environment.

Qualifications

Minimum NFQ Level 7 Qualification in Engineering or Manufacturing.
3 years in a Manufacturing / Science or Engineering environment.
GMP/GDP experience.
ISO 13485 experience.
Yellow belt qualification desired.

Responsibilities

Apply quality principles, analyses quality records, prepares reports and recommends improvements.
Conduct inspection, verification and validation of components or materials used in development processes.
Identify and address recurring problems with product quality or testing procedures.
Document quality issues and performance measures for management review.
May liaise with external vendors.
Monitor and maintain validation status of site products, processes and systems and monitor process FMEA and CQAs.
Provide regular updates on project resource requirements and ensure other quality functions are involved in projects.
Report on actions to reduce non-conformances and initiate CAPA.

Skills

Quality engineering

GMP/GDP

ISO 13485

Yellow belt

Education

NFQ Level 7 Qualification in Engineering or Manufacturing

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 114,000 colleagues serve people in more than 160 countries.

Abbott in Ireland

Abbott has been operating in Ireland since 1946 and serves the Irish market with a diverse range of healthcare products including diagnostics, diabetes care, medical devices and nutritional products. In Ireland, Abbott currently employs about 6,000 people across ten sites located in Dublin, Donegal, Clonmel, Cootehill, Galway, Kilkenny, Longford and Sligo.

Please note any offer of employment for this position isconditional upon the successful completionof a pre-employment medical examination, including drug and alcohol screening, conducted by a medical practitioner designated by the Company.

Abbott Diabetes Care Kilkenny

Abbott Diabetes Care has opened a new site, in Kilkenny, that is at the forefront of Diabetes care with the latest technology, to manufacture FreeStyle blood glucose test strips and FreeStyle Sensors for use in diabetes management. Among Abbott Diabetes Care leading brands are the FreeStyle Precision, FreeStyle Lite and FreeStyle Libre systems.

This is how you can make a difference at Abbott:

As an Operations Quality Engineer you will Analyse quality standards for components, materials or services. Apply measures, sampling methods, testing methodology and other procedures that ensure that quality standards are met. Provide Quality expertise and guidance to Manufacturing/Operations, Technical/Product Test and Incoming Materials to support the manufacture and delivery of quality and compliant products on time, in full and cost effectively to meet the needs of the business and customers.

This is a shift based role on 4 cycle shift.

Responsibilities:

Apply quality principles, analyses quality records, prepares reports and recommends improvements.
Conduct inspection, verification and validation of components or materials used in development processes.
Identify and address recurring problems either with the quality of the product or the reliability of testing procedures.
Document quality issues and performance measures for management review.
May liaise with external vendors.
Monitor and maintain the validation status of site products, processes and systems and monitor and maintain process FMEA and Critical Quality Attribute systems. Maintain site validation plans and periodic review process. Support Equipment and Software validation activities and support Process validation activities
Provide regular updates to peers and colleagues on project resource requirements and ensure other quality functions are brought into project teams at appropriate points.
Report on and support the implementation of actions to reduce the occurrence/reoccurrence of non-conformances within Manufacturing, Product Test and Incoming Material and initiating Exception Reports for discrepancies observed during inspection / testing & review activities.
Present and communicate status, report metrics, identify trends potential issues, improvement initiatives and CAPA requirements.
Investigating customer complaints and forwarding reports to PQA group and responsible for maintaining Corrective and Preventive Action programs.
Responsible for maintaining an appropriate balance of quality, compliance and business risk and responsible for ensuring teams use appropriate risk management tools to prioritize certain activities and justify the level of effort required.
Monitor and maintain the quality and compliance status of associated quality records and ensure project teams maintain project records in compliance with Quality System and planned requirements.
Support DMR change control and calibration activities.