Quality Validation Engineer – Medical Devices

Abbott Laboratories; Kilkenny; Hybrid; EUR 60,000 - 90,000; Full time

Benefits offered by this job

Family health insurance

Excellent pension scheme

Life assurance

Career Development

Fantastic new facility

Growing business plus access to many —

Job summary

Abbott Diabetes Care Kilkenny seeks a Quality Validation Engineer to create and maintain validation documentation for systems and processes, ensuring compliance with Abbott Quality System requirements and regulatory standards.

You will work on validation for equipment, processes, facilities, and systems used in manufacture, control, and storage of products, with opportunities to collaborate with global teams and travel to vendor locations across Europe and the United States for training.

Qualifications

• Bachelor's Degree in Engineering, Science, Manufacturing, Quality, or a related discipline.
• Minimum 4 years' experience within an Engineering, Manufacturing, Scientific, or Quality environment.
• 5+ years' experience in validation, including process, equipment, facilities, utility, and/or software validation.
• Experience working within a regulated industry such as Medical Devices, Pharmaceuticals, Biotechnology, or Healthcare.
• Strong working knowledge of FDA 21 CFR Part 820, ISO 13485, and associated quality system requirements.
• Experience authoring and reviewing validation lifecycle documentation.
• Understanding of risk management principles and validation best practices.

Responsibilities

• Support the development, implementation, and continuous improvement of the site Validation Program.
• Develop, review, execute, and maintain validation documentation, including protocols, reports, risk assessments, and validation plans.
• Ensure validation activities are performed in compliance with divisional procedures, regulatory requirements, and industry best practices.
• Develop and maintain Quality System procedures, work instructions, and training materials.
• Monitor and maintain the compliance status of validation and quality records.
• Review and approve validation documentation in accordance with company policies and procedures.
• Collaborate with Quality, Engineering, Manufacturing, and Operations teams to support validation and compliance objectives.
• Support internal, customer, and regulatory audits as required.
• Track and communicate validation metrics, compliance trends, risks, and continuous improvement initiatives.
• Contribute to maintaining a high-performing quality culture that ensures the delivery of safe and effective products.
• Support activities related to Design Controls and Design Transfer where required.

Skills

Problem solving

Communication

Stakeholder management

Education

Bachelor's Degree in Engineering/Science/Manufacturing/Quality

Job description

Abbott Diabetes Care Kilkenny seeks a Quality Validation Engineer to create and maintain validation documentation for systems and processes, ensuring compliance with Abbott Quality System requirements and regulatory standards.

You will work on validation for equipment, processes, facilities, and systems used in manufacture, control, and storage of products, with opportunities to collaborate with global teams and travel to vendor locations across Europe and the United States for training.