Job Description
Job Summary:
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.
Authority Assignment:
In the absence of the Senior Quality Systems engineer the QS Engineer will report to the QA/RA Director.
Duties/Responsibilities:
- 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.
Specific Requirements:
- 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 / talent@hero.ie
Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie
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