This successful West of Ireland Medical Device manufacturing facility with over 300 employees and more than 1000 worldwide, is looking for a skilled professional to join its team. Due to recent business developments, the company require a skilled Sterilisation Quality Engineer to support on manufacturing activities.

The Role:

Reporting to the Quality Engineering Manager and supported by the Quality Assurance team, the Sterilisation Quality Engineer will be required to carry out the following activities:

• Be site SME for all sterilisation activities, providing technical excellence in the field of gamma and ethylene oxide (EO) sterilisation methods.
• Support on manufacturing processes and lead process improvement initiatives to reduce cost and increase efficiency.
• Lead sterilisation validation for new products and change control.
• Non-conforming material investigation, customer complaints, CAPA investigation, analysis and improvement.
• Review, update, maintain and improve existing quality documentation.
• Maintain sterilisation programs (evaluation of changes, EO requalification).
• Conduct product and method/process validations, implementing method, process, product and material changes through documentation updates.
• Supporting the introduction of new product lines through development of product inspection plans, process FMEAs and risk management plans.
• Conduct internal audits and cost audits of the company's operations by external bodies (e.g. audits from customers, audits relating to certification to official standard e.g. ISO 13485).
• Conform to onsite quality and environmental management systems.

The Person:

The ideal candidate will have the following:

• A degree in Quality Assurance or equivalent.
• At least 5 years' experience quality engineering / sterilisation / microbiology role, ideally in medical device manufacturing engineering environment.
• Experience of draft/review SOP and sterilisation validation documentation, highly advantageous.

To discover more about this opportunity, apply now or contact Aidan Toner on +353 91 782 110 for a confidential discussion.