Overview
Job 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:
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 the opportunity to work directly onsite, collaborating with manufacturing and quality teams to drive compliance improvements and process validation initiatives.
Hours of work:
Monday-Friday 39 hours per week with a 1:00pm Friday finish.
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.
Contact:
Rachel Mc Mahon for more information
Email:
******
Phone:
**********
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