Manufacturing Engineer

1 hour ago

Galway, Ireland Cregg Recruitment Full time

Job Title: Manufacturing Engineer(Med Device Manufacture) Hours: Hybrid role 3 days on site with a 1pm Friday finish and free on-site gym. 39hr week offering flexitime Location: Galway Industry:Medical Devices Company information: Galway's world leading multinational Medical device company Contact: To discuss email CV to or call Manufacturing Engineer: Medical Devices Galway's world leading medical device manufacturing company have available opportunities for EXPERIENCED Manufacturing Engineers to join their team. Please send CV to to apply. About the role: Purpose: To support a critical site-wide remediation program following an FDA 483 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. Key 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: Bachelors degree in Engineering or related discipline. 25 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:/ INDCRG Skills: manufacturing validation NPI

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