Manufacturing/Quality Engineer

1 week ago

Galway, Galway, Ireland Oxford Global Resources Full time

Manufacturing/Quality Engineer – Oxford Global Resources
Overview
Technical Recruiter at Oxford International is seeking a Quality/Manufacturing Engineer for a site-wide remediation program following an FDA 483.
The role focuses on manufacturing process validation, quality system updates, and documentation remediation.
Consultants will work onsite with manufacturing and quality process owners to identify compliance gaps, implement corrective actions, and ensure documentation is accurate and audit-ready.
Responsibilities
Partner with process owners on the floor to capture and remediate issues.
Support process validation (IQ/OQ/PQ) and documentation updates.
Drive CAPA/NCR closure and implement compliant solutions.
Provide technical writing for quality and manufacturing documents.
Collaborate cross-functionally to ensure regulatory compliance.
Qualifications
Engineering or Quality degree with 5-10 years\' med-tech experience.
Background in remediation, process validation, CAPA, NCRs.
Strong technical writing and documentation skills.
Knowledge of 21 CFR Part 820, ISO 13485.
Job Details
Seniority level: Entry level
Employment type: Full-time
Job function: Quality Assurance
Industries: Pharmaceutical Manufacturing
Location: Galway, County Galway, Ireland
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