CAPA Engineer

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. 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 a CAPA Engineer you will facilitate and execute the CAPA process. You will also support continuous improvement and effective maintenance of the QMS. Ensure the use of appropriate risk management tools to prioritise activities. Key Responsibilities Participate in the completion of CAPA projects, ensuring compliance, and quality of records. Collaborate with cross-functional teams using various methodologies (e.g. Six Sigma root cause analysis/problem solving skills). Independently investigate, gathers data, and perform preliminary analysis. Process requests, ensuring owners are assigned, and timely responses and approvals are provided in alignment with quality goals. Identify trends potential issues, improvement initiatives. Ensure on-time completion of Quality Assurance engineering deliverables. Support team in the delivery and oversight of CAPA training program. Identify projects to enhance and promote effectiveness, and efficiency of the quality system and product quality. Support Operations to make Quality / Compliance decisions on product during processing, manufacturing, testing, monitoring and packaging. Provide support and subject matter expertise during audits and inspections. Qualification and Experience Minimum Level 7 NFQ qualification or equivalent in a relevant discipline. Min of 4 years experience in Engineering/Manufacturing/Scientific environment. Previous CAPA and/or quality assurance/engineering experience. Ability to demonstrated use of quality tools/methodologies. Knowledge of FDA Quality System Regulations (21 CFR Part 820), GMP, and ISO 13485: 2016. Good communication and interpersonal skills. Previous project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner. Advanced computer skills, including statistical/data analysis and report writing Skills 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 or on LinkedIn at on Facebook at and on Twitter @AbbottNews. Abbott is an equal opportunities employer. The base pay for this position is N/A

JOB DESCRIPTION:

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 a CAPA Engineer you will facilitate and execute the CAPA process. You will also support continuous improvement and effective maintenance of the QMS. Ensure the use of appropriate risk management tools to prioritise activities. Key Responsibilities

• Participate in the completion of CAPA projects, ensuring compliance, and quality of records.
• Collaborate with cross-functional teams using various methodologies (e.g. Six Sigma root cause analysis/problem solving skills).
• Independently investigate, gathers data, and perform preliminary analysis.
• Process requests, ensuring owners are assigned, and timely responses and approvals are provided in alignment with quality goals.
• Identify trends potential issues, improvement initiatives.
• Ensure on-time completion of Quality Assurance engineering deliverables.
• Support team in the delivery and oversight of CAPA training program.
• Identify projects to enhance and promote effectiveness, and efficiency of the quality system and product quality.
• Support Operations to make Quality / Compliance decisions on product during processing, manufacturing, testing, monitoring and packaging.
• Provide support and subject matter expertise during audits and inspections.

Qualification and Experience

• Minimum Level 7 NFQ qualification or equivalent in a relevant discipline.
• Min of 4 years experience in Engineering/Manufacturing/Scientific environment.
• Previous CAPA and/or quality assurance/engineering experience.
• Ability to demonstrated use of quality tools/methodologies.
• Prior medical device experience preferred.
• Knowledge of FDA Quality System Regulations (21 CFR Part 820), GMP, and ISO 13485: 2016.
• Good communication and interpersonal skills.
• Previous project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
• Advanced computer skills, including statistical/data analysis and report writing Skills

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.

Connect with us at or on LinkedIn at on Facebook at and on Twitter @AbbottNews. Abbott is an equal opportunities employer. The base pay for this position is N/A In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Operations Quality

DIVISION:

ADC Diabetes Care

LOCATION:

Ireland > Kilkenny : Kilkenny Business and Technology Park

ADDITIONAL LOCATIONS:

WORK SHIFT:

Ie - Shftpre0 (Ireland)

TRAVEL:

Yes, 20 % of the Time

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Not Applicable Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott  welcomes and encourages diversity in our workforce. #J-18808-Ljbffr