QA Senior Specialist, EMEA Division
Develops and applies sound knowledge and understanding of QA frameworks, legislative requirements, processes, and procedures in the EMEA distribution organisation.
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Key Responsibilities
* Ensures compliance with the ISO 9001 standard across UK & BNN sites.
* Develops and maintains the QMS and documentation system to ensure sites operate within approved Corporate and Regional EMEA processes and procedures.
* Maintains quality records to provide evidence that the QMS is being followed.
* Supports annual Management Reviews of the Quality System.
* Conducts internal quality audits and supports continual improvements of the QMS.
* Collaborates with process owners to implement corrective actions.
* Develops a QMS training program and provides update training as necessary.
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Requirements
* BSc degree in a relevant field; an Advanced Degree is preferred.
* 2-4 years of relevant experience.
* Project support and time management skills.
* Knowledge and application of quality requirements, including ISO 9001.
* Technical knowledge of medical device quality requirements.
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Skills
* Strong IT skills, including Microsoft Office.
* Fluent in English (and local language where applicable).