Validation Specialist
We are seeking a skilled Validation Specialist to join our team. As a key member of the Quality department, you will play a vital role in ensuring the quality and integrity of our products.
* The ideal candidate will have 2+ years' experience in validation engineering, with a strong background in medical device manufacturing, CAPAs, and GMP environments.
* Proven track record of working in highly regulated environments, with knowledge of ISO Standards and Lean Six Sigma methodologies.
In this role, you will be responsible for developing and implementing solutions to maintain and improve our Quality Management System (QMS). This includes:
* Writing and monitoring quality and validation protocols and standards.
* Generating risk assessments, covering cleaning, validation, and process.
* Supporting compliance to ISO 13485 and ISO 14001 systems standards.
* Participating in site change control, ensuring all changes to validated processes are effectively identified and implemented.
You will also have opportunities to support continuous improvement through Lean Six Sigma methodologies and execute change controls.
This is an exciting opportunity for an experienced validation specialist looking to take their career to the next level.