This position is responsible for providing subject matter expertise in the Non-Conforming (NC), Corrective Action Preventive Action (CAPA) process. Coordinating key elements of the NC/CAPA System to ensure compliance to relevant standards for the business including EN ISO13485:2016, MDSAP and FDA requirements. This role will take the lead in ensuring that the NC/CAPA System is maintained and implemented in a compliant manner and areas of improvement are identified and executed as required. The individual will serve as a point of contact and assist with planning, investigating and implementing improvements to products and processes.
In the absence of the Senior Quality Systems engineer the QS Engineer will report to the QA/RA Director.
- 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.
- Co-ordinate all phases of the NC/CAPA process for specific events; including documentation, record management, and assembly of robust NC/CAPA files.
- 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.
- Provide assistance in generation of management review metrics for NC/CAPA as required.
- A degree in Engineering, Technology, or Science
- At least 3-5 years’ experience working in a regulated medical device preferably with CAPA experience or pharmaceutical company.
- Excellent planning and coordination skills.
- Excellent verbal and written communication skills.
- Excellent attention to detail skills.
- Ability to work within a team environment to achieve agreed company goals.
- 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 projects
- Ability to communicate quality / regulatory concepts effectively.
- Good understanding of EN ISO 13485:2016, MDSAP and FDA regulations.
- Ability to prioritize, plan & evaluate deliverables to established strategic goals
- Ability to interact professionally with all organizational levels
- Proficiency in use of desktop software applications such as MS office.
- Some travel may be required with the role.
Typical office environments, with work also performed in R&D and manufacturing labs, and customer/supplier locations.
For further information on this Quality Systems Engineer role in Galway please contact Orla on 086 0449473 / firstname.lastname@example.org
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