We are seeking a Manufacturing Process Specialist to support our large upcoming site-wide project.
Job Description
This role will focus on manufacturing process validation, quality system updates, and documentation remediation. The ideal candidate will identify compliance gaps, implement corrective actions, and ensure documentation is accurate and audit-ready.
Key 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.
Requirements:
* 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.
What We Offer:
* Competitive employee compensation package.
* Pension contributions.
* Health insurance.
* Paid public holidays.
Location: Galway, Ireland onsite