Senior Quality Engineer – Senior Quality Engineering Professional
A senior quality engineering professional is required by CareerWise Recruitment for a leading health care organization based in East Galway. The role is an initial 12‑month contract position.
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.
Job 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, e.g., MES and ERP.
Experience in management of BOMs and manufacturing paperwork translation to digital platforms is an advantage.
Experience in DHR/DMR management and collating through electronic systems and MES.
Experience in audit and presenting electronic DHR is an advantage.
Please call Laura Gallagher today for further information on 087‑4526468 or email: lgallagher@careerwise.ie
About CareerWise Recruitment
CareerWise Recruitment specialises in recruiting management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. Established in 1999, we operate across multiple locations in Ireland.
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