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CSV - Quality Assurance Specialist

Job Field:
Regulatory and Drug Safety Jobs
QA Jobs
Belgium All
Contract Type:
Salary Description:
Clinical Professionals
Job Ref:

CSV - Quality Assurance Specialist
Location- Leuven, Belgium
Type: Permanent Full-time
Salary - competitive
MedTech Professionals is working with an international client based in Leuven. If you have valuable working experience within the Quality Assurance field as well as solid know-how of Computerised System validation, please contact me TODAY: +32 (0) 2 892 3993. As this career opportunity happens once in a lifetime!
Main responsibilities:
In charge of the CSV for the companys site in Belgium;
Responsible for the improvement of the Quality Management System (QMS) according to ISO 9001 and ISO 13485;
Monitor compliance of the EMEA QMS to external quality and regulatory requirements, ensure procedures and instructions are aligned and changes are processed according to Change Management process;
Support the implementation, maintenance and improvement of quality systems based on information in the organisation's strategic plan, audits, changes in ISO and the priorities within the organization;
Perform Software and process Validation activities linked to QMS;
Ensure that all procedures relating to the quality, safety and environment system are created and kept up to date;
Monitor and manage non-compliances and CAPA activities, enable rapid and effective correction of quality problems in a manner that prevents their reoccurrence;
Implement, monitor and maintain the complaint handling processes;
Minimum of 3 years of working experience with Quality Systems in particular on the validation of the computerized systems and process validation;
Knowledge of ISO Standards (13485) and FDA requirements;
English & Flemish spoken to a native level is needed. And any other EU languages would be a plus.

If this role is not suited to you, please feel free to share the details within your professional network as we do operate a generous bonus referral scheme should we then go on to place someone that you recommend to us.
To apply for this position, or for further information, please call Yasmina Mallem directly on
+32 (0) 2 892 3993. Alternatively you can email on if you have any further questions, please do get in contact!

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