Remediation Quality Engineer
3 weeks ago
Overview
Our client, a leading medical technology company in Galway, is seeking experienced
Remediation Quality Engineers / Manufacturing Engineers
to support a critical site-wide remediation program following an FDA 483 observation.
This role offers a fantastic opportunity to work directly onsite, collaborating closely with manufacturing and quality teams to drive compliance improvements and process validation initiatives.
Key Responsibilities
Partner with manufacturing process owners to identify and remediate compliance gaps.
Support manufacturing process validation activities (IQ/OQ/PQ).
Update quality system documentation and technical files to ensure audit readiness.
Drive closure of CAPAs and NCRs with effective corrective actions.
Provide clear and concise technical writing for quality and manufacturing procedures.
Collaborate cross-functionally with Quality, Manufacturing, and Regulatory teams to implement compliant solutions.
Qualifications & Experience
Bachelor's degree in Engineering or Quality-related discipline.
2–5 years of experience in medical device manufacturing, quality, or remediation projects.
Strong knowledge of process validation (IQ/OQ/PQ) and CAPA/NCR management.
Proven technical writing and documentation skills.
Familiarity with 21 CFR Part 820 and ISO 13485 quality standards.
Excellent problem-solving skills with the ability to take a problem statement through to a compliant solution.
Must be available to work onsite in Galway.
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