Quality Engineer
My client, a global pharmaceutical and medical device company, who specialises in developing and manufacturing of human pharmaceutical products, seeks to hire a new Quality Engineer.
Supporting the Post Market QA team, supports the Business Units fulfil their statutory duties to carry out Post Market Surveillance activities.
This role will suit someone from the pharma/medical device, with experience in Quality Management Systems, who wishes to grow their career in a world-renowned organisation.
This is a 12-month contract position, based on site at their site on in Galway City.
Responsibilities
- Responsible for displaying professional behaviour with both internal and external business associates that reflects favourably on the company and is consistent with the company's policies and practises.
- The obligation to comprehend and uphold knowledge of the potential negative effects of performing their profession incorrectly.
- Completes challenging assignments by possessing and using extensive understanding of Quality and its application to the realm of post-market surveillance.
- Acquires in-depth knowledge of global operations and structures to make wise judgements and give guidance to the BU Quality and Regulatory teams and other functional areas.
- Delivering initiatives on behalf of the Division and with the assistance of the Business Units is your responsibility.
- Drives cross-functional compliance in coordination with the divisional for teamwork and multi-site conformance to pertinent regulatory standards.
- Provide resolutions with the best possible outcome in ambiguous circumstances and occasionally with incomplete information, agreement is sought. utilises risk assessment procedures under these conditions.
- Carry out any additional tasks or projects that are given to you.
Requirements
- 3rd level qualification science or a related discipline.
- 3 years’ experience in the medical device industry, specifically in a regulated environment. For example, CE, FDA, PAL, IVDR, MDSAP.
- Experience in development of medical devises, desirable.
- Proficient in MS Suite.
For more information, please contact [email protected]
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