Temporary Quality Engineer
Our client, a medical device company in Galway are currently looking to recruit a Temporary Quality Engineer for their site.
- At our Quality Department in the company, we focus on supporting and improving our quality system. Quality engineers are directly involved in quality operations support across a range of products.
- 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.
- Leadership Expectations provide the framework for what we expect from all employees at the company - outlining the actions and behaviours we must develop and demonstrate in pursuit of our Mission and global growth goals.
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