Our client is a global leader in the Medical Devices industry sector. They have undergone significant growth this year, and are seeking an experienced Quality Engineer II to join the Design Assurance Group at their state-of-the-art facility in Galway.
This group focus on providing Quality support across all aspects of PDP from pre-market product development to post-market product surveillance.
Duties and responsibilities of the Quality Engineer II will include:
- 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
You will have skills and experience in the following:
- Minimum of Degree level 8 in Engineering / Science or related discipline
- 2+ years of relevant industry experience
- Experience working in the medical device or other regulated industry
- In-depth knowledge of GMP and documentation practices for a technical/professional working environment
- You must think critically and make sound decisions
- Excellent oral and written communication skill
To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 6321885 for a confidential discussion.