Quality Assurance Engineer (Sterilisation)
Reporting to the Quality Engineering Manager, the Quality 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.
Essential duties and responsibilities include the following. Other duties may be assigned as required:
- 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 re-qualification).
- 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 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.
QUALIFICATIONS AND EXPERIENCE REQUIRED:
- A Degree in Quality Assurance or equivalent.
- Minimum of 5 year’s experience in a quality engineering / sterilisation / microbiology role, preferably in the Medical Device sector.
Kelly Services are acting as an Employment Agency in relation to this role. Should you choose to apply, your information will be processed in accordance with Kelly’s Privacy Statement.
As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.
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