A Senior Quality Engineering Professional is required by CareerWise Recruitment for our client, a leading health care organization, based in East Galway for an initial 12-month contract role.
The Senior Quality Engineering Professional will lead digital quality initiatives and support the integration of automated, data-driven processes across manufacturing and quality systems.
THE ROLE:
* 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 (FDA, EU MDR, ISO standards).
* Collaborate with cross-functional teams to embed quality assurance into digital workflows, MES (Manufacturing Execution Systems) and ERP Systems.
* Monitor and validate data integrity across digital platforms used in production and quality control.
REQUIREMENTS:
* 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, ie. MES and ERP
* Experience in management or routers/Bill of Materials (BOMs) and associate milestones in manufacturing paperwork/translation to a digital platform an advantage.
* Experience in DHR/DMR management/collation through use of electronic systems and MES.
* Experience in audit and presenting pm electronic DHR an advantage.
Please call Laura Gallagher today for further information on 087- 4526468 or email: lgallagher@careerwise.ie
CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.
We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.
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