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Quality Assurance Engineer
Our Client a Medical Device company in Roscommon have an exciting new Quality Assurance role available:
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.
The Responsibilities of the Quality Assurance Engineer:
- Review, update and maintain 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,
- 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 9001, ISO 13458)
- Maintain detailed and accurate quality records, data analysis and documentation,
- Non-conforming Material, 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.
- A Degree in Quality Assurance or equivalent
- Minimum of 2 years’ experience in a Quality Engineering role, preferable in the Healthcare/Medical Device Sector.
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