Overview
Excellent opportunity for a Quality Engineer to join a Biotech company in Mayo. The Quality Engineer will report to the QA Manager and will be responsible for implementing all elements of the QMS while collaborating with the US team to share and apply best practices across both sites. The ideal person will have an operational Quality background in MedTech or Biotech, experience with auditing and have experience influencing various stakeholders including clients.
Responsibilities
Manage QC/QA activities using the company’s MRP/MES systems to ensure product quality and regulatory compliance.
Support production quality, raw material inspection, product release, and quality investigations.
Assist with supplier onboarding, documentation, performance monitoring, and supplier audits.
Manage relationships and compliance with sterilization providers.
Support cleanroom certification, equipment/process validation, and calibration compliance.
Monitor quality KPIs and support continuous improvement of the QMS.
Assist with customer audits, documentation, and issue resolution.
Knowledge, Skills and Experience Required
Level 8 degree in Engineering, Science, or Quality Assurance.
5+ years’ experience in a regulated quality role.
Experience in GMP, cleanroom, or pharmaceutical environments.
Knowledge of radiation sterilization (gamma/X-ray) and validation.
Supplier auditing or lead auditor experience is an advantage.
Strong decision-making and ability to manage priorities independently.
Proficient in MS Office (Outlook, Word, Excel).
Excellent communication, organization, and attention to detail.
Team player with ability to drive quality improvements.
For a confidential discussion and more information on the role contact Courtney Russell
courtney.russell@collinsmcnicholas.ie
+353 (0) 71 9108062
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