Senior Quality Systems Specialist

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Job Function:
Quality

Job Sub Function:
Quality Systems

Job Category:
Professional

All Job Posting Locations:
Nijmegen, Netherlands

Job Description:

GATT Technologies is recruiting for a Senior Quality Specialist, located in Nijmegen.

Join our dynamic team as a Senior Quality Specialist and play a pivotal role in ensuring the reliability and excellence of ETHIZIA, our innovative hemostatic sealing patch.

Your expertise will directly impact patient outcomes, making a difference in surgical procedures worldwide while advancing the field of medical technology.
Key Responsibilities:

Under the management of the Quality Systems Lead, the Senior Quality Systems Specialist acts as supervisor to Nonconformance / CAPA process and support to the Change Control / Training management process for the GATT site as well as supports External Audit management process.

This position drives the continuous education, implementation and improvement of Quality Systems and compliance with QS regulation and ISO within the GATT facility and ensures that the site's QMS Processes and structure meet all business and regulatory requirements.

Furthermore, this position acts as the backup of the Quality Systems Lead and provides guidance and assistance to ensure compliance of process procedures with applicable regulations and standards, such as, good laboratory practices, good clinical practices, quality system regulations, and organization of international standards including administrative support to the Quality organization.
Key responsibilities include:


* Supervisor to Nonconformance / CAPA, Escalation process and support to the Change Control / Training management process at the site and ensures adherence of the process at the site as well as acts as SME for this process during regulatory inspections


* Uses complex statistical methods, quality tools and computer-generated reports to continuously improve process capability


* Provides education/training as needed regarding QMS process


* Acts as process owner for data analysis to the DRB and preparation to Management Review, as appropriate


* Quality Planning: Coordinates the control of...