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Quality Systems Engineer
Our client, a medical device company in Galway is currently looking to recruit a Quality Systems Engineer for their site
Working in the QA Department, this person will take day- to-day responsibility for the running of QA based systems; Document control, running of NCR and CAPA systems, oversight of the internal auditing process and other systems as required. They will also take a lead role in supplier management and will be the QE contact in relation to incoming inspection process. This function will liaise with various departments to ensure the quality system is in compliance and will have a team of up to 4 people reporting into this role.
Role & Responsibilities:
- Identify and implement effective process control systems to support the continuous improvement of the quality systems as a whole
- Oversee and be actively involved in all QA office systems and functions.
- Direct involvement in incoming inspection and supplier management
- Develop and implement quality metrics and reporting systems.
- Support and deliver continuous improvements and to employ problem solving tools including root cause analyses and CAPA identification.
- Preparation of Quality reports for Quality meetings and management reviews
- Take a lead in the implementation of process controls and CAPA systems designed to meet or exceed internal and external requirements
- Acts as an effective team member in supporting quality disciplines, decisions and practices.
- Apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating and resolving quality issues.
- Ensure regulatory compliance to GMP for all medical device regulatory agencies
- Suggest changes in procedures and standards to facilitate work efficiency and maintain quality
- Reporting Functional area Quality Metrics
- Perform an active role in continual improvement of the Quality System
- Conduct internal quality audits to ISO13485 and GMP requirements.
- Report on Key Performance Indicators (KPIs) in order to adhere to process and prevent occurrence of any non-conformity relating to product, process or system
- Undertake special projects as required
- Contribute to continuous improvement activities
- Take part in third part audits as required.
- Min 4 year industry experience in a medical device manufacturing company.
- Science/ Engineering/Quality Degree and relevant experience required.
- Previous experience within the medical device industry in Quality / Engineering is essential.
- Good working knowledge of ISO13485 systems
- Knowledge and Experience of Statistical Process Control would be beneficial.
- Excellent Computer Skills (Word, Excel, Powerpoint and Access)
- Excellent communication (both verbal and written) & interpersonal skills
- Flexible, highly motivated individual and accountable
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