Job Reference: FRS35437
Job Duration:
Start date: 05/12/2019
Description:
QA Sterilisation Engineer
Commutable from Galway/ Mayo/ Sligo/ Longford/ Offaly
Delighted to be assisting my client once again recruit a QA Microbiologist to expand their Quality Assurance team in a Medical Device Company -commutable from Roscommon/ Galway/ Mayo/ Sligo/ Longford/ Offaly. If you have a minimum 5 years' experience as Quality Engineer/ QA Microbiologist within sterilisation and are looking for your next move, then I would love to hear from you.
About the role
Reporting to theQuality Engineering Manager you will provide ongoing support to the manufacturing team to maximise production quality performance, including identifying root cause, implementing corrective/preventive action on all quality issues in production. You will lead sterilisation validation for new products and change controls. Scope of role will also include addressing any customer related issues identified in the manufacturing process and validation of new processes/products.
You will have the opportunity to:Improve, maintain and review quality management processes and procedures.
Ensure quality standards are adhered to, and SOP'sfollowed in line with ISO standards.
Drive continuous improvement programs.
Be the 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 change controls and maintain sterilisation programs.
Ensuring compliance to all relevant regulations for sterilisation and microbiology which includes maintaining all quality systems and related documentation.
Maintain detailed and accurate quality records, data analysis and documentation.
Non-conforming material investigation, customer complaints, CAPA investigation, analysis and improvement.
Data analysis and trending, statistical process control, root cause analysis and the implementation of corrective actions.
Ensure quality inspection instruments are accurate and regularly calibrated, tested and audited.
Prepare and execute process/product validations.
Ensure new product introductions and change controls are effectively managed inaccordance with the ISO requirements when appropriate.
Supporting the introduction of new product lines through development ofproduct inspection plans, process FMEAs and risk management plans.
Conduct internal audits.
Prepare for external audits.
Conform to the requirements of the quality and environmental management systems.
Requirements:
A Degree in Quality Assurance or equivalent.
Minimum of 5 years' experience in a quality engineering / sterilisation / microbiology role, preferably in the Medical Device sector.
For more information please don't hesitate to call Felicity on 086 7821714 to discuss the role in more detail.
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Industry: Manufacturing and Production
Salary:
Salary Benefits:
Vacancy Type: Permanent
Job Skills: -
Contact Name: FELICITY FARRELL
Website: -
Direct Application URL: -