Quality Engineer

19 hours ago

Galway, Ireland Oxford Global Resources Full time

Our client, a leading medical technology company in Galway, is seeking experiencedRemediation Quality Engineers / Manufacturing Engineersto 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 ***** 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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