Our client, a medical device company in Galway are looking for Quality Engineer to join their growing team. This is a 12 month contract, Initially working from home role but you may need to attend the lab as required. As a Quality engineer you will be responsible for
- Ensure, maintain and enhance compliance within Design Assurance Laboratory
- Lead Laboratory team in Quality decisions and behaviours
- Adhere to all Design Assurance Laboratory and relevant site wide procedures and practices for Safety & GMP
- Support review and release of test data
- Develop & maintain a deep understanding of processes and products to support process improvements
- Lead Audit preparation and follow up
- Drive laboratory investigations, identifying root causes using robust root cause analysis tools and sound engineering principles
- Initiate corrective and preventative actions and follow through to implementation
- Support Change Control - Initiate Change Orders to support documentation updates, draft changes & justifications, and drive to completion in a timely manner
- Devise and lead continuous improvements activities within the Design Assurance Lab
KEY SKILLS & EXPERIENCE
- Minimum level 8 in Engineering / Science or related discipline
- Minimum of 2 years of relevant experience.
- Ideally you will have experience in the medical device or other regulated industry.
- Knowledge of GMP and documentation practices for a technical/professional working environment
- As this role is working from home it is important that you are a strong communicator and can work well on your own initiative.