Validation Engineer
We are currently seeking a skilled and experienced Validation Engineer to join our medical manufacturing team based in Ireland.
This role will play a key part in supporting the qualification and validation of new tools and product introductions. If you have a passion for process validation, experience working with ISO 13485 standards, and skills in injection moulding or medical manufacturing environments, this could be an ideal opportunity for you to grow your career.
The successful candidate will be responsible for writing, executing and reviewing process validation protocols and reports as well as developing solutions to sustain and improve our Quality Management System (QMS). They must maintain compliance with ISO 13485 systems standards while participating in site change control initiatives. The individual should also perform risk assessments covering cleaning, validation processes etc., review execute Factory Acceptance Testing (FAT) protocols Site Acceptance Testing (SAT), support GMP regulatory audits deliver training modules using Lean Six Sigma methodologies lead root cause analysis implement corrective actions work closely within cross-functional teams identifying implementing improvements ensuring overall efficiency effectiveness quality standards adhered.