QA Validation Engineer

Job description

JOB DESCRIPTION:

Have you ever wanted to make a difference?

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 that enable 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:

In this role you will be responsible for creating and implementing the Abbott Division validation program. Creating and maintaining validation documentation for new and existing systems and processes subject to design control. You will also ensure that validation activities are implemented for systems and processes used to manufacture, control and store intermediates and finished products to requirements and standards as listed in the current Quality Systems Manual.

You will also have the opportunity to travel to vendor locations for training in Europe or the US

Responsibilities

· 
The development and maintenance of Quality System procedures.

· 
Ensuring the site delivers safe and effective products that meet customer needs whilst maintaining compliance.

· 
Monitoring and maintaining the quality and compliance status of associated quality records.

· 
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.

· 
The review and approval of validation documentation in accordance with divisional policies.  

· 
Basic understanding of design controls and design transfer.

Qualifications & Experience

· 
Relevant NFQ Level 7 Qualification in Engineering/Manufacturing/Science is preferred.

· 
Minimum 3 years in the Engineering/Manufacturing/ Scientific field.

· 
3-5 years working knowledge of process, equipment, facilities and or software validation either within Quality or Engineering departments

· 
Experience with supporting Supplier Validations, Supplier Changes, Supplier Management and Component Qualification; preferably experience with Injection Moulding, Metal forming / stamping, and metrology.

· 
Some travel required, up to 40%

· 
Experience working in a 21CFR820 and/or ISO13485 regulated industry. May consider experience in pharmaceutical validations

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 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 - Shftpre0 (Ireland)

     

TRAVEL:

Yes, 20 % of the Time

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable