Technical Recruiter at Oxford International
Project Description
We are seeking experienced Remediation Manufacturing Engineers to support a site-wide remediation program following an FDA 483.
The role focuses on manufacturing process validation, quality system updates, and documentation remediation.
Consultants work onsite with manufacturing and quality process owners to identify compliance gaps, implement corrective actions, and ensure documentation is 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 of med-tech experience.
Background in remediation, process validation, CAPA, NCRs.
Strong technical writing and documentation skills.
Knowledge of 21 CFR Part 820, ISO *****.
Location
Galway, County Galway, Ireland
Employment Type
Full-time
Job Function
Quality Assurance
Industry
Medical Equipment Manufacturing
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