I'm working with a medical device start-up company near Galway city. Their product is an innovative medical device that has moved to clinical trial. During this exciting phase, they are now looking to increase their headcount, meaning they'd like a Quality System Engineer (at either an experienced or senior level) to join them.
They are located in Galway's medical device hub. Their facilities are also expanding, which is their headquarters. Culture here is collaborative, hard-working and very friendly. From top-down, they want to see you succeed.
My client are looking for who is experienced working in a quality-systems orientated position within the medical device industry. You will work establish and maintain effective quality system structures to ensure consistent implementation of quality systems.
Reporting to the Senior Quality Manager, some of your responsibilities will include:
- Being a leader and expert in the areas of quality systems, medical device standards Regulations
- Leading and managing the alignment of the QMS to the requirements of ISO13485:2016 & 21CFR820.
- Leading and supporting Regulatory Inspections and Notified Body audits.
- Compiling Management Review data, Quality metrics and driving continuous improvements in the quality system.
- Being responsible for the Internal Audit process, CAPA & non-conformance processes and Complaints process within the organization.
- Conducting internal audits to schedule and maintaining/supporting the supplier quality management process.
You have a scientific/technical/engineering degree (hons/level 8) with at least 3 yrs. experience of working as a Quality Systems Engineer/similar within the Medical Device Industry. You thrive work in a busy, fast-paced environment and have experience in the above responsibilities. You'd like to work in a company with a company during an exciting growth phase.
If you think you might be interested in becoming a Quality Systems Engineer in Galway and looking for more information, I will contact you upon application and discuss this further with you
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