Our client, a leading manufacturer of medical devices serving the global marketplace based in Connacht are seeking an experienced Sterilisation Engineer to work within the Quality Assurance Team. This role will report directly to the Quality Engineering Manager. You will be providing ongoing manufacturing support to the manufacturing team to maximise production quality performance.
Duties and responsibilities of the Sterilisation Engineer will include:
- Site SME for all sterilisation activities, providing technical excellence in the field of gamma and ethylene oxide sterilisation methods
- Lead sterilisation validation for new products and maintain sterilisation programs
- Ensure compliance to all relevant regulations for sterilisation and microbiology which includes maintaining all quality systems and related documentation
- Review, update, maintain and improve existing quality management processes and procedures
- Raise quality profile, initiate and drive continues improvement programs
- Supporting the introduction of new product lines through development of product inspection plans, process FMEAs and risk management plans
- Host audits of the company's operations by external bodies
You will have skills and experience in the following:
- Degree in Quality Assurance or equivalent
- Minimum 5 years' experience in a quality engineering/sterilisation/microbiology role, preferably in the Medical Device sector, Pharmaceutical, Biopharmaceutical or similar
For more information on this opportunity, talk to Laura Gallagher in confidence, email or call her direct line 091782113.