Overview
Job Title:
Manufacturing Engineer (Med Device Manufacture)
Hours:
Hybrid role 3 days on site with a 1pm Friday finish and 39-hour week offering flexitime
Location:
Galway
Industry:
Medical Devices
Company information:
Galway's world leading multi-national Medical device company
Contact:
To discuss email CV to or call
About the role
Purpose:
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.
Hours of work:
Monday-Friday 39hr week with a 1pm Friday finish.
Responsibilities
Identify and remediate compliance gaps.
Support manufacturing process validation activities (IQ/OQ/PQ).
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 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.
Contact:
Rachel Mc Mahon for more information
Email:
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