Remediation Manufacturing Engineers
3 weeks ago
Our client, a leading medical technology company in Galway, is seeking experienced Remediation 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.
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.
- 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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Remediation Quality Engineer
3 weeks ago
Galway, Galway, Ireland Oxford Global Resources Full timeOverviewOur 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...
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Remediation Quality Engineer
3 weeks ago
Galway, Galway, Ireland Oxford Global Resources Full timeOverviewOur 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...
-
Remediation Quality Engineer
3 weeks ago
Galway, Galway, Ireland Oxford Global Resources Full timeOverviewOur 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...
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Manufacturing Engineer
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Quality/Manufacturing Engineer
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Remediation Compliance Expert
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Galway, Galway, Ireland Oxford Global Resources Full timeAre you a manufacturing engineer looking to progress your career?Are you interested in taking the next step in your professional journey with a global leader in the medical device industry?Are you ready to challenge yourself in a fast-paced and high-regulated environment?You could be the perfect candidate for this opportunityDon't hesitate, apply todayJob...
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Manufacturing Engineer
3 weeks ago
Galway, Galway, Ireland Oxford Global Resources Full timeAre you a manufacturing engineer looking to progress your career? Are you interested in taking the next step in your professional journey with a global leader in the medical device industry? Are you ready to challenge yourself in a fast-paced and high-regulated environment? You could be the perfect candidate for this opportunity Don't hesitate, apply...
