What you need to know
Do you want to work for a leading innovative Medical Device Company in Galway?
Continue to read if so…
You will work as a Quality Engineer for our client within the Coronary Design Assurance Group, here they focus on providing Quality support across all aspects of PDP from pre market product development to post market product surveillance. You will participate in the design process to ensure the performance and safety of the coronary devices our client develops is assured and maintained throughout the product lifecycle.
The company is a leading organisation in their field.
This is an initial 12-month contract role.
Your new job
Key duties & responsibilities 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
What are we looking for?
- Minimum of Degree level 8 in Engineering / Science or related discipline with a minimum of 2 years of relevant 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
- Strong analytical/problem-solving skills
- Fosters collaborative relationships within the team and across the organization
- Excellent oral and written communication skill
- Be focused on patient and customer and set high standards, instil operational excellence, and drive accountability
Apply for this job now or get in touch with Aoife at email@example.com