Remediation Manufacturing Engineers

2 days ago

Galway, Ireland Oxford Global Resources Full time

Our client, a leading medical technology company in Galway, is seeking experiencedRemediation 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.

  • Manufacturing Engineer

    15 hours ago

    Galway, Ireland Oxford Global Resources Full time

    Are you a Manufacturing engineer looking for a new opportunity? Don't hesitate and apply today! PROJECT DESCRIPTION We are seeking experienced Remediation Manufacturing Engineers to support a site-wide remediation program following an FDA 483. These roles will focus on manufacturing process validation, quality system updates, and documentation remediation....

  • Manufacturing Engineer

    1 hour ago

    Galway, Ireland Oxford Global Resources Full time

    Are you a Manufacturing engineer looking for a new opportunity?Don't hesitate and apply today!PROJECT DESCRIPTION We are seeking experienced Remediation Manufacturing Engineers to support a site-wide remediation program following an FDA 483.These roles will focus on manufacturing process validation, quality system updates, and documentation...

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    3 days ago

    Galway, Ireland Oxford Global Resources Full time

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  • Manufacturing/Quality Engineer

    2 days ago

    Galway, Ireland Oxford Global Resources Full time

    Are you a Quality/Manufacturing engineer looking for a new opportunity?Don't hesitate and apply todayPROJECT DESCRIPTIONWe are seeking experienced Remediation Quality Engineers / Manufacturing Engineers to support a site-wide remediation program following an FDA 483.These roles will focus on manufacturing process validation, quality system updates, and...

  • Manufacturing Engineer

    7 days ago

    Galway, Ireland Cregg Full time

    OverviewJob Title:Manufacturing Engineer (Med Device Manufacture)Hours:Hybrid role – 3 days on site with a 1:00pm Friday finish; 39 hour week with flexible time.Location:GalwayIndustry:Medical DevicesCompany information:Galway's world-leading multi-national Medical device companyContact:To discuss, email CV to ****** or call **********About the...

  • Manufacturing Engineer

    2 weeks ago

    Galway, Ireland Cregg Full time

    OverviewJob Title:Manufacturing Engineer (Med Device Manufacture)Hours:Hybrid role – 3 days on site with a 1:00pm Friday finish; 39 hour week with flexible time.Location:GalwayIndustry:Medical DevicesCompany information:Galway's world-leading multi-national Medical device companyContact:To discuss, email CV to ****** or call 0860127415About the...

  • Manufacturing Engineer

    2 days ago

    Galway, Ireland Cregg Full time

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    6 days ago

    Galway, Ireland Cregg Full time

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    4 days ago

    Galway, Ireland CREGG Full time

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  • Manufacturing Engineer

    2 days ago

    Galway, Ireland Oxford Global Resources Full time

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