Job Description:
We are seeking a seasoned Quality Engineering Professional to lead digital quality initiatives and support the integration of automated, data-driven processes across manufacturing and quality systems.
The ideal candidate will have a strong understanding of FDA, ISO 13485, and EU MDR standards, as well as experience with digital quality systems, including MES and ERP. Additionally, they should have excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams.
Key Responsibilities:
* Maintain and improve the Quality Management System (QMS) in alignment with ISO 13485 and FDA regulations.
* Support digital transformation initiatives by integrating quality controls into automated and data-driven manufacturing processes.
* Ensure compliance with applicable regulatory requirements.
* Collaborate with cross-functional teams to embed quality assurance into digital workflows.
Requirements:
To be successful in this role, you will need:
* A bachelor's degree in Engineering, Quality, or a related field.
* 5+ years of experience in quality engineering within a regulated manufacturing environment.
* Strong understanding of FDA, ISO 13485, and EU MDR standards.
* Experience with digital quality systems, including MES and ERP.
* Excellent communication and collaboration skills.
Benefits:
This is an excellent opportunity to work with a leading healthcare organization and contribute to the development of their quality management system. You will have the chance to work with a talented team and develop your skills and knowledge in quality engineering.
About Us:
We are a recruitment agency specializing in the life sciences, ICT, engineering, food, and agri sectors. We operate out of multiple locations in Ireland and have offices in various cities.