Senior Quality System Engineer with 8 years experience & good understanding of ISO 13485, MDSAP and FDA regulations required for permanent role with growing Irish company in Galway
- Document control function including co-ordination of DCR process and ongoing compliance, in conjunction with the appropriate resources
- Record management system (the computerized quality system tracking tool) and Quality records storage. This includes development and improvement projects, as appropriate
- Generation of reports for data trending and analysis of the quality system (as required)
- Co-ordinate all phases of the NC/CAPA process for specific events; including documentation, record management, and assembly of robust NC/CAPA files
- With the support of subject matter experts (SMEs), drive investigations, perform robust root cause analysis, develop and implement corrective actions, and establish effectiveness monitoring plans
- Serve as a resource to NC/CAPA investigations for conducting root cause analysis and developing and implementing corrective action plans
- Maintain and manage positive working relationships and ensure appropriate representatives from affected departments are involved while assisting in all stages of NC/CAPA system and resolution
- Ensure that every activity performed in the NC/CAPA process is accurately documented and that all timeframes for reporting or resolution are met
- Aid in generation of management review metrics for NC/CAPA and Document Control as required
- May assist or perform internal audits and assist in preparation for external audits, as required
- Bachelor’s degree (Hons) in Engineering, Technology, or Science. (Level 8).
- At least 8 years’ experience working in a regulated environment.
- Previous people management experience.
- Good understanding of EN ISO 13485:2016, MDSAP and FDA regulations.
- Ability to prioritize, plan & evaluate deliverables to established strategic goals
- Excellent planning and coordination skills.
- Excellent verbal and written communication skills.
- Excellent attention to detail skills
- Ability to manage competing priorities in a fast-paced environment
- Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
- Ability to interact professionally with all organizational levels
- Proficiency in use of desktop software applications such as MS office.
- Some travel will be required with the role.
Please contact Emer Smith to discuss in confidence