Operations Quality Engineer - Shift

Abbott Laboratories; Kilkenny; On-site; EUR 65,000 - 90,000; Full time

Benefits offered by this job

Family health insurance

Life assurance

Fantastic new facility

Growing business plus access to many

Job summary

Abbott in Kilkenny is seeking an Operations Quality Engineer to analyze quality standards across components and materials, applying sampling methods and testing to ensure compliance. You will provide quality guidance to Manufacturing/Operations and Product Test to deliver on-time, in-full, cost-effective products for the business and customers.

The role is shift-based on a 4-cycle shift, with responsibilities spanning inspection, validation, CAPA, and collaboration with vendors.

Qualifications

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

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.

Education

Minimum NFQ Level 7 Qualification in Engineering or Manufacturing

3 years in a Manufacturing / Science or Engineering environment

GMP/GDP experience

ISO 13485 experience

Job description

Location Ireland - Kilkenny Category Quality

Abbott has maintained a strong presence in Ireland since 1946 and celebrates its 80th anniversary in the country in 2026. The company supports the Irish healthcare sector with a broad portfolio spanning diagnostics, diabetes care, medical devices and nutritional products. Today, Abbott employs more than 6,500 people across ten sites located in Dublin, Donegal, Clonmel, Cootehill, Galway, Kilkenny, Longford and Sligo.

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 122,000 colleagues serve people in more than 160 countries.

Abbott Diabetes Care

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.

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

What we Offer

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

• Family health insurance,
• Life assurance
• Fantastic new facility
• Growing business plus access to many more benefits.

Connect with us at www.abbott.com or https://www.ie.abbott/, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.

Abbott is an equal opportunities employer.

ENGINEERING INNOVATION THAT ADVANCES DIABETES CARE

INNOVATIVE BENEFITS

We support our colleagues around the world as they care for themselves and their families with offerings tailored to their unique needs.

DIVERSITY & INCLUSION

We strive to provide environments where all employees feel welcome and able to bring their full selves to work. To do this we integrate diversity, equity, and inclusion across Abbott.

SUSTAINABILITY FOR OUR FUTURE

At Abbott, sustainability means managing our efforts so we can help the greatest number of people around the world live fuller lives through better health.

WE'RE RECOGNIZED AROUND THE WORLD

DOW JONES SUSTAINABILITY INDEX

BEST CORPORATE CITIZENS

FORTUNE CHANGE The WORLD

FORTUNE'S MOST ADMIRED COMPANIES

JOIN OUR TALENT COMMUNITY

We will notify you about relevant positions, and keep you in mind when we have interesting opportunities.

EQUAL OPPORTUNITY STATEMENTS

An Equal Opportunity Employer

Abbott is an Equal Opportunity Employer. We are committed to providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local law. Employment decisions are based on qualifications, merit, and business needs.

EEO (ENGLISH)

EEO (SPANISH)

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

We provide reasonable workplace accommodations. U.S. residents only: To request accommodation, please call 224-667-0340 or email [e-mail].

Abbott is committed to pay equity and transparency. Compensation is determined using objective, job-related, and gender-neutral criteria in compliance with applicable laws and local regulations.

Job Details

Job Id 31163802 Location Ireland - Kilkenny Medical surveillance Not Applicable Division ADC Diabetes Care Travel Not specified Additional Location Significant work activities Not Applicable.