Medical Device Manufacturing Engineer
3 days ago
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 rachel@cregg.ie or call 0860127415
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 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.
Contact: Rachel Mc Mahon for more information
Email: rachel@cregg.ie / 0860127415
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