Temporary Quality Engineer
Our client, a medical device company in Galway are currently looking to recruit a Temporary Quality Engineer for their site.
- You will contribute to investigating root cause of quality issues and following through on corrective actions to prevent reoccurrence.
- You will provide quality engineering support to Operations, helping to drive efficiency improvements.
- You will support on-going communication through reports and information transfer as needed.
- You will participate in understanding and ensuring compliance with the company's external regulatory quality systems requirements.
- You will develop and maintain analysis techniques and other quality control tools to aid in decision making.
- You will generate an understanding of product construction, features and uses at a competent level in order to make decisions on product acceptance standards within their scope of responsibility.
- We are looking for a qualified person to Third Level Degree in Science, Engineering or related discipline and desirably with 2/3 years relevant experience.
- You are a dynamic team player and leader and can work effectively and proactively on cross-functional teams.
- You are experienced in a Pharmaceutical Technology, Combination Product or related environment with direct experience in a QA environment (GMP regulated).
- A good working knowledge of process validation requirements, statistical techniques and project management are required. Knowledge of regulatory requirements and guidelines, namely CFR parts210, 211 and 280, ICH and ISO 13485 is necessary.
- Ability to be self-directed and to effectively interface with various levels and functions within the organization is essential.
- Experience in conducting stability studies and knowledge of cleaning validation would be desirable.
- You are a good communicator and fluent in English, both in writing and speaking.
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