Principal Consultant – Life Sciences and Engineering (CareerWise Recruitment)
Senior Quality Engineering Professional is required for a leading health care organization located in East Galway. The role is a 12‑month contract and focuses on leading digital quality initiatives and integrating automated, data‑driven processes across manufacturing and quality systems.
Role Overview
The Senior Quality Engineering Professional will:
* 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 (MES and ERP).
* Experience managing BOMs and associated milestones in manufacturing paperwork/translation to a digital platform is an advantage.
* Experience with DHR/DMR management and collation through electronic systems and MES.
* Experience in audit and presenting electronic DHR.
Please call Laura Gallagher today for further information at 087-4526468 or email: lgallagher@careerwise.ie.
CareerWise Recruitment (In Search of Excellence) is a specialist recruiter established in 1999. We focus on recruitment of management and technical professionals for the life sciences, ICT, engineering, food, and agriculture sectors across multiple locations in Ireland.
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Details
Seniority Level: Mid‑Senior level
Employment Type: Contract
Industry: Medical Equipment Manufacturing
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