Operations Quality Engineer

6 months ago

Kilkenny, Ireland Abbott Full time

At Abbott, you will play a crucial role to help people live more fully at all stages of their lives. Abbott is a global healthcare leader, and our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional products and branded generic medicines. Our 113,000 colleagues have a daily impact on the life of people in more than 160 countries.

Abbott Ireland

In Ireland, Abbott employs over 5,000 people across nine sites. We currently have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott also has commercial, support operations and shared services in Dublin and Galway. We have been making a difference in the lives of Irish people since 1946.

Diabetes Care Kilkenny

Our new manufacturing facility in Kilkenny, opening in 2024, reflects the growing demand for Abbott's global Diabetes Care products. The facility will be a centre for world-class engineering, quality, medical device manufacturing, and other science-based professionals to produce life-changing technologies, including the FreeStyle Libre 3, a system that automatically delivers real-time, up-to-the-minute glucose readings, with the smallest and thinnest wearable glucose sensor that provides unsurpassed 14-day accuracy and optional glucose alarms directly to smartphones. This enables people with diabetes to live the best and fullest lives they can.

At Abbott in Kilkenny, you can shape your career as you help shape the future of healthcare. 

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.
 

Key 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

Two 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.

Abbott is an equal opportunities employer.

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