Quality Operations Shift Lead

Abbott; Kilkenny; On-site; EUR 70,000 - 100,000; Full time

Benefits offered by this job

Family health insurance

Excellent pension scheme

Life assurance

Career Development

Fantastic new facility

Growing business plus access to many更多

Job summary

Abbott in Kilkenny is seeking an Operations Quality Shift Lead to supervise manufacturing inspection and test functions across all stages of production. You will lead a team, drive quality assurance, ensure compliance, and support continuous improvement of the Quality Management System.

This role requires a NFQ Level 7 qualification in science/engineering or manufacturing, plus 4 years in manufacturing and 2 years of people leadership. GMP/GDP experience and ISO13485 exposure are prized.

Qualifications

• NFQ Level 7 qualification in Science/Engineering or Manufacturing.
• Minimum of 4 years' experience in Manufacturing.
• Minimum 2 years' experience people management.
• Yellow belt qualification desired.
• Strong communication and organisation skills.
• Experience with GMP/GDP.
• ISO13485 experience.

Responsibilities

• Oversees operational implementation of quality assurance strategies and regulations.
• Completes the assessment of potential risks, ensures compliance, and gives recommendations to management.
• Supervises team to ensure quality control aspects of the process are met (laboratories studies, clinical research, testing, operations, raw materials, production, finished product or services).
• Facilitates audits and regulatory inspections.
• Liaises with external vendors, contractors, or suppliers to ensure that their products or services meet the organisation's quality standards.
• Lead a team of Operations Quality engineers.
• Manage functional area's compliance to site and divisional policies and procedures.
• Lead the continuous improvement and effective maintenance of the QMS.
• Subject Matter Expert in use of risk management tools to prioritise activities and justify the effort required.
• Accountable for building and maintaining successful cross functional relationships with departments such as R&D, Technical, Engineering, Operations and Regulatory Affairs in order to achieve all project goals.
• Manage teams Health and Safety within the working environment; highlight opportunities for improvement to EHS performance.
• Act as Lead for the monitoring and compliance of the Quality Management System as it applies to site Operations:
• Lead team in making Quality / Compliance decisions on product during processing, manufacturing, testing, monitoring, and packaging.
• Lead audit readiness in functional area
• Identify and lead projects to enhance and promote the effectiveness and efficiency of the quality system and product quality.
• Champion a "right first time" approach to Quality Records by ensuring accountability for functional responsibilities.

Skills

Quality leadership

Communication skills

Problem solving

Team leadership

Regulatory awareness

Education

NFQ Level 7 Science/Engineering or Manufacturing

Tools

GMP/GDP

ISO13485

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

Abbott in Ireland

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.

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

Diabetes Care Kilkenny

Our new manufacturing facility in Kilkenny, 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 Shift Lead, you will be responsible for general supervision of the manufacturing inspection and test functions at every stage of the manufacturing process. May supervise inspection and test activities of operators. Performs function failure testing as well as physical defects. This is a shift role on 4 cycles.

Key Responsibilities

• Oversees operational implementation of quality assurance strategies and regulations.


• Completes the assessment of potential risks, ensures compliance, and gives recommendations to management.


• Supervises team to ensure quality control aspects of the process are met (laboratories studies, clinical research, testing, operations, raw materials, production, finished product or services).


• Facilitates audits and regulatory inspections.


• Liaises with external vendors, contractors, or suppliers to ensure that their products or services meet the organisation's quality standards.


• Lead a team of Operations Quality engineers.


• Manage functional area's compliance to site and divisional policies and procedures.


• Lead the continuous improvement and effective maintenance of the QMS.


• Subject Matter Expert in use of risk management tools to prioritise activities and justify the effort required.


• Accountable for building and maintaining successful cross functional relationships with departments such as R&D, Technical, Engineering, Operations and Regulatory Affairs in order to achieve all project goals.


• Manage teams Health and Safety within the working environment; highlight opportunities for improvement to EHS performance.


• Act as Lead for the monitoring and compliance of the Quality Management System as it applies to site Operations:


• Lead team in making Quality / Compliance decisions on product during processing, manufacturing, testing, monitoring, and packaging.


• Lead audit readiness in functional area


• Identify and lead projects to enhance and promote the effectiveness and efficiency of the quality system and product quality.


• Champion a \"right first time\" approach to Quality Records by ensuring accountability for functional responsibilities.

Education and Experience

• A minimum of a NFQ Level 7 Qualification in Science / Engineering or Manufacturing qualification


• Minimum of 4 years' experience in Manufacturing


• Minimum 2 years' experience people management


• Yellow belt qualified desired


• Strong communication and organisation skills


• Strong problem solving


• Experience with GMP/GDP


• ISO13485 experience

What we Offer

• 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.

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 or email