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 114,000 colleagues serve people in more than 160 countries.
Abbott in Ireland
Abbott has been operating in Ireland since **** and serves the Irish market with a diverse range of healthcare products including diagnostics, diabetes care, medical devices and nutritional products.
In Ireland, Abbott currently employs about 6,000 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 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 *****: ****.
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 - Kkyflx (Ireland)
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable