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.
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 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.