Operations Quality Engineer Shift

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 114000 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 Ireland Abbott currently employs about 6000 people across ten sites located in Dublin Donegal Clonmel Cootehill Galway Kilkenny Longford and Sligo.

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.

Qualifications and Experience

• Minimum NFQ Level 7 Qualification in Engineering or Manufacturing qualification

• 3 years in a Manufacturing / Science or Engineering environment

• GMP/GDP experience

• ISO 13485 experience

• Yellow belt qualification desired.

What we Offer

Attractive compensation package that includes competitive pay as well as benefits such as

• Family health insurance

• Excellent pension scheme

• Life assurance

• Career Development

• Fantastic new facility

• Growing business plus access to many more benefits.

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Abbott is an equal opportunities employer.

The base pay for this position is

In specific locations the pay range may vary from the range posted.

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