Quality Validation Engineer

Job Description:

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 1946 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 Libre 3 continuous glucose monitoring sensors for use in diabetes management. Among Abbott Diabetes Care leading brands are the FreeStyle Precision, FreeStyle Lite and FreeStyle Libre systems.

Main purpose of the role
In this role you will be responsible for implementing the Abbott Division validation programme. Creating and
maintaining validation documentation for new and existing systems and processes subject to design /change control. Applies
subject matter knowledge. You will also ensure that validation activities are implemented for components, systems and processes
used to manufacture, control and store intermediates (sub-assemblies) and finished products to requirements and standards as
listed in the current Quality Systems Manual.

Main responsibilities
* The development and maintenance of Quality System procedures.
* Investigates/troubleshoots validation problems for components, equipment and/or performance processes.
Monitoring and maintaining the quality and compliance status of associated quality records.
* Writes, reviews, approves and/or executes documentation for new and current validation procedures and technical reports
related to components, equipment, facilities/utilities, products and/or processes.
* May assist with establishing corporate validation policies.
* Maintaining the quality and compliance status of associated Procedures, work instructions and training materials.
* Presenting and communicating status, report metrics, identify trends potential issues, improvement initiatives, as applicable.
Basic understanding of design controls and design transfer.
* May be responsible for creating, updating or participating in risk analyses and FMEAs.
* May be responsible for change assessment to ensure product quality and compliance.

Qualifications & Experience
* Relevant NFQ Level 7 Qualification in Engineering/Manufacturing/Science is preferred.
* Minimum 2 years in the Engineering/Manufacturing/ Scientific field.2-3 years working knowledge of process, equipment, facilities and or software validation either within Quality or Engineering departments.
* Experience working in a 21CFR820 and/or ISO13485 regulated industry. May consider experience in pharmaceutical validations.

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.

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:
Yes, 10 % of the Time

MEDICAL SURVEILLANCE:
No

SIGNIFICANT WORK ACTIVITIES:
Not Applicable