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Quality Assurance Administrator

2 months ago


Tipperary, Ireland LGC Clinical Diagnostics Full time
Job Description

In this role, you will be responsible for coordinating the control, distribution, and management of Quality documentation that supports our quality management systems. This includes processing and approving document change requests and ensuring timely notification of changes to relevant parties. Additionally, you'll be tasked with maintaining various logs for tracking documentation and tasks, ensuring accuracy and efficiency in our processes.

Supporting our Internal Audit program will be another key aspect of your role, where you'll participate in audits and implement corrective actions, as necessary. It's important that you demonstrate a deep understanding of Quality Policies and system procedures, and the process to promptly report any noncompliance issues to management.

 


Qualifications

To apply for this position, you should have a degree in a Science, Engineering, or QA field or you have experience in our industry/regulated environment for medical devices.

Basic knowledge of FDA 21CFR820, ISO13485, IVDD98/79/EC, IVDR EU/2017/746. 

International regulatory requirements is essential.

Strong communication skills and attention to detail are also important attributes for success in this role.

If you're passionate about quality and eager to contribute to a dynamic team in a regulated environment, we want to hear from you



Additional Information

LGC, Diagnostics & Genomics (D&G) is committed to creating a diverse and inclusive workplace where everyone is valued and respected. We believe in equal opportunity for all employees and applicants, regardless of race, color, religion, gender, sexual orientation, national origin, age, disability, or any other legally protected status.

We actively seek to foster an environment where all individuals can thrive and contribute to our shared success. Our hiring practices are designed to ensure that all candidates are treated fairly and evaluated based on their qualifications, merit, and alignment with our organizational values.

 

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