- 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.
- Relevant third level qualification. Engineering/Manufacturing/Science is preferred.
- Minimum 3 years in the Engineering/Manufacturing/ Scientific field.
- 7 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
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Quality Validation Engineer - Kilkenny, Ireland - Abbott Laboratories
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, 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:
In the role of Quality Validation Engineer, 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
It will be a very big plus if you can bring experience in developing projects or sites from square one.
You will be responsible of:
QUALIFICATIONS AND EXPERIENCE
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Abbott is an equal opportunities employer.
