Quality Engineer - Validation

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 114000 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 Ireland Abbott currently employs about 6000 people across ten sites located in Dublin Donegal Clonmel Cootehill Galway Kilkenny Longford and Sligo.

Abbott Ireland Nutrition Sligo

We understand that proper nutrition is the foundation for living the best life possible. Thats why we develop science-based nutrition products for people of all ages. Our products help babies and children grow keep bodies strong and active and support the unique nutrition needs of people with chronic illnesses to make every stage of life a healthy one.

Abbott is a leader in providing enteral nutrition feeding devices including enteral feeding pumps and pump sets. Enteral feeding (also known as tube feeding) is a means of providing nutrition to people who cannot obtain nutrition by swallowing. Enteral nutrition contains all the calories and vitamins a person needs.

Abbotts journey in Ireland began in 1974 with our first manufacturing facility in Sligo. Over the years weve transformed from manual operations to a state-of-the-art fully automated facility. Now located in Carbury Point Finisklin Sligo our award-winning site is recognized for operational excellence safety training and community involvement. The prestigious Shingo Prize for Operational Excellence highlights our commitment to continuous improvement and a culture of excellence delivering sustainable results year after year.

Primary Function / Goals / Objectives

Reporting to the Senior Validation and Sterilisation Engineer you will have responsibility for the day to day operation of the quality system ensuring assigned areas are effectively managed and all elements are in compliance with the requirements specified by ANSC Sligo Device Quality System ISO 13485 Medical devices - Quality Management System and in all other relevant international standards.

Major Responsibilities

• Coordinating appropriate assigned elements of the Quality System ensuring full compliance by all relevant plant personnel with its requirements. These primarily consist of; Co-ordination of design control validation and change control programmes. Performance of Risk Assessments and associated Risk documentation.
• Assist in the investigation and coordination of design control validation and change control related customer complaints/Non-Conformances assess need for implementation of effective corrective/preventative actions or update to the risk management file.
• Review and approval of all documents generated in Validation Management System (M-Files).
• Management of key site projects and liaison with all key internal and external stakeholders. Measure performance of the Quality System and providing metrics for inclusion in the management review monthly and quarterly reports etc.
• Ensure all plant personnel are fully aware of quality requirements (where relevant) by providing the necessary training where relevant including M-Files system and Validation Program Training.
• Ensure management are kept informed of all system failures on a regular basis to ensure corrective/preventive action is taken where necessary.
• Ensure implementation and compliance with relevant regulatory requirements.
• Audit the Quality System with other management personnel where required. Support of Supplier Audits and internal audit programme where required.

EHS Responsibilities:

• Ensure Environmental Health & Safety standards are met and all EHS regulations and procedures are adhered to.
• Demonstrate accountability and responsibility for EHS performance and compliance through active participation and support of Abbotts EHS Program
• Ensure to report any work related injuries or illness to employee health and assist in the investigation.
• Active participation and support of Abbotts EHS programs and attend EHS training as assigned. Meet EHS plant goals

Education/skills/knowledge

• Educated to degree or diploma in an engineering science or quality-related discipline or an equivalent combination of education and work experience.
• Strong working knowledge of quality systems regulations (IS013485/lS09000) or individual elements within the regulations such as; design control production and process controls change control lean principles etc.
• Proven Validation skills in a regulated environment.
• Risk management skills including risk assessment and an understating of IS014971.
• Proven project management and organisational skills.
• Excellent interpersonal/communication skills.
• Enthusiastic and energetic with the ability to integrate quickly into a team environment
• Self-starter with proven ability to work on own initiative.
• Demonstrate flexible and innovative approach to work
• Previous experience of working in a multinational and/or regulated medical device manufacturing organization is desirable
• Previous Audit Experience End to End sterilisation experience experience in relation to Medical Device Regulation MDR 2017/745 is desirable

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The base pay for this position is

In specific locations the pay range may vary from the range posted.

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