Our client a healthcare company in Westmeath is looking for a Quality Engineer to Provide Quality Engineering & Quality Assurance expertise to the Quality department to ensure the Quality System is of the highest standard. Safeguard the quality of all products produced to ensure all customer and regulatory requirements are met.
- Responsibility for investigations into Product/Process non-conformances and customer complaints on both Medical and non-medical products.
- Maintain a quality system compliant to the ISO standards ISO13485, ISO9001 & IATF standard IATF16949 and all applicable regulations under associated directives.
- Responsibility for managing Suppliers and performing internal & external audits
- Lead cross functional teams in completing Product and Process risk assessments under ISO 14971
- Perform an active role in quality planning and new product introduction
- Lead cross functional teams in continuous improvement activities, championing a structured approach to problem solving.
- Lead cross functional teams in managing change controls across the Plant.
- Provide training in Quality Processes and Procedures to the extended production and technical support team
Quality Assurance Team:
- Work Closely with the Quality Team, providing support in other areas where required
- Good communication written or verbal to build excellent relationships with customers through frequent contact and visits when required
Sales & Marketing:
- Liaise with the Sales and Marketing Department learn customers from them.
- Liaise on Quality Issues
Product Development Department:
- Be involved from the beginning on new projects ensuring that there is a focus on quality from the beginning
The Successful Candidate
- Have a relevant 3rd level qualification with 3+ years quality experience post-graduation
- Experience with IATF 16949 and ISO 13485 regulations
- Experience in moulding environment (injection or blow moulding) preferred
- Experience in driving continuous improvement projects is essential
- The ability to blend best practices from different methodologies to deliver results (Six Sigma, Lean, Kaizen)
- Demonstrated methodical and analytical approach
- Strong attention to detail with structured approach to planning & organising
- Be able to work on own initiative and priorities work as required
- Have excellent communication skills
For further information on this Quality Engineer role in Westmeath please contact Orla on 086 0449473 / email@example.com
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