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QA Sterlisation Engineer

QA Sterilisation Engineer
Permanent position
Location: County Roscommon

Ready to join one of the truly great companies in Ireland?

We have a really exciting job opportunity for a QA Sterilisation Engineer based in Roscommon. Join a super team of people and a company that offers exceptional salaries and rewards. This company provides innovative technical solutions and manufacturing services for Med Tech companies and high potential start ups.

Reporting to the Quality Engineering Manager, the QA Sterilisation Engineer will provide ongoing support to the manufacturing team in an effort to maximise production quality performance, including identifying root cause, implementing corrective/preventive action on all quality issues in production. Scope of role will also include addressing any customer related issues identified in the manufacturing process and validation of new processes/products.

Responsibilities

Review, update, maintain and improve existing quality management processes and procedures.
Ensure quality standards are adhered to, and all production processes are carried out according to procedures.
Raise quality profile and operating standards within the business.
Initiate and drive continuous improvement programs.
Ensure that the company retains ISO accreditation.
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 change control.
Maintain sterilisation programs (evaluation of changes, EO requalification).
Ensure 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 in accordance with the ISO requirements when appropriate.
Supporting the introduction of new product lines through development of product inspection plans, process FMEAs and risk management plans.
Conduct internal audits.
Host audits of the company's operations by external bodies (e.g. audits from customers, audits relating to certification to official standard e.g. ISO 13458).
Conform to the requirements of the quality and environmental management systems.Experience

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 further information on this role please contact Elaine Ferguson on or (phone number removed)

Check out all our open jobs on our HERO Recruitment website - (url removed) Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval. Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel
Posted
07/08/2022
Location
Roscommon, IE