Validation Quality Engineer New - Cork

Role Purpose

To lead and execute validation activities for medical devices, ensuring full compliance with applicable regulatory standards and quality system requirements.

• Manage and execute process and software validation activities in a regulated medical device environment.
• Serve as the primary point of contact for all validation execution activities on-site in Fermoy.
• Investigate and resolve validation-related issues effectively and efficiently.
• Standardize validation and qualification practices across all projects and systems.
• Provide technical direction and support for the development, execution, and review of validation protocols and documentation.
• Maintain up-to-date knowledge of current GMP and regulatory requirements to support compliance across the site.
• Oversee the validation lifecycle, including scheduling and conducting Periodic Reviews.
• Support change control processes related to process and facility modifications.

• Ensure validation practices meet internal quality standards and external regulatory requirements.
• Assist in audits and inspections, providing validation documentation and expertise.

• Adhere to all relevant Health & Safety regulations, ensuring safe execution of validation activities.

• Timely, accurate completion of validation tasks and documentation.
• Demonstrated compliance with applicable regulatory and quality standards.

Qualifications & Experience

Required:

• Level 7 qualification (QQI) in Science, Electronics, Mechanical, or Industrial Engineering.
• Minimum of 2 years’ experience in Quality Assurance or Regulatory Affairs.
• Practical experience in conducting Process Validations aligned with CDRH Guidance.
• Proficiency in GAMP 4/5 software validation methodologies.
• Strong problem-solving and analytical skills.
• Skilled in Microsoft Word, Excel, and PowerPoint.
• Ability to draft SOPs, training materials, and regulatory submissions.
• Experience with statistical tools, Design of Experiments (DOE), and DMAIC.

Preferred:

• Experience in a regulated Medical Device Manufacturing environment.
• Fluency in German.
• Certified Six Sigma Green Belt or Black Belt.
• Knowledge of electronic manufacturing processes.

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