A Quality Engineer is sought by a Med Device Company in Sligo to provide technical quality support to various teams.
The ideal candidate will have a strong knowledge of ISO 13485, FDA regulations, and MDR requirements, as well as experience in medical device manufacturing and validation.
Key responsibilities include quality review of process validation plans, coordination of compliant product risk management files, and issue and review of lot records.
A minimum degree in a Science or Engineering discipline and 3-5 years' experience in a medical device environment are required.
Strong written and verbal communication skills, self-motivation, and excellent attention to detail are essential.
Proficiency in MS Office and a high level of teamwork and engagement are also required.
* Key Responsibilities:
* Quality review of process validation plans and protocols
* Coordination of compliant product risk management files
* Issue and review of lot records to manufacturing
* Coordination and review of testing and release of sterilised product
* Requirements:
* Minimum degree in Science or Engineering discipline
* 3-5 years' experience in medical device environment
* Strong knowledge of ISO 13485, FDA regulations, and MDR requirements
* Experience in medical device manufacturing and validation
* Strong written and verbal communication skills
* Self-motivation and excellent attention to detail
* Proficiency in MS Office
* High level of teamwork and engagement