Job Title:
Quality Assurance Specialist
Description:
We are seeking a Quality Assurance Specialist to join our team in Galway. The successful candidate will be responsible for ensuring the quality of our products and processes, and will play a key role in maintaining our company's reputation for excellence.
The Role:
This is an exciting opportunity for a motivated and detail-oriented individual to join our team as a Quality Assurance Specialist. Reporting to the COO, you will be responsible for implementing and maintaining our Quality Management System (QMS), supervising quality technicians and engineers, and overseeing internal audits and supplier control.
Responsibilities:
1. Maintain and report on the performance of the QMS to senior management
2. Supervise quality technicians and engineers in completing departmental activities
3. Oversight of quality system including management reviews, internal audits and supplier control
4. Manufacturing validation including development, protocols and reports
5. Customer complaints analysis and approval of reports
6. CAPA/NCR investigation and timely closure
7. Lot release and external audits including FDA and Notified Body
8. Operations support to meet objectives of quality, cost and output
Requirements:
1. Bachelor's degree in a scientific discipline with 4 years' experience in medical device or pharmaceutical industry
2. Demonstrated knowledge of ISO 13485 and 21 CFR 820 requirements
3. Ability to work as part of a team and meet targets efficiently
4. Demonstrated organisational, management and communication skills
5. Good interpersonal and communication skills essential
6. Strong knowledge of quality principles
About Us:
We are a start-up based in Galway, Ireland. We are committed to delivering high-quality products and services to our customers.
How to Apply:
Please submit your application, including your CV and cover letter, to us. We look forward to hearing from you.