Reference Number: JO-1908-435053
Quality System Specialist EMEA
Job Type: Permanent
Quality Assurance Specialist – EMEA
Location- Office based/Zaventem, Belgium
Salary – competitive
MedTech Professionals is working with a global client based in the Zaventem area of Belgium. If you have solid working experience within the Quality field and specifically with QMS and ISO 13485, please contact me TODAY: +32 (0) 2 892 3993. As this career opportunity happens once in a lifetime!
Responsible for the maintenance/ 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 Process Validation activities linked to QMS.
Provide QA Introduction Training, ISO 13485 Introduction training and training on procedures under EMEA QMS .
Ensure that all procedures relating to the quality, safety and environment system are created and kept up to date.
Control/audit systems in order to guarantee compliance and to initiate and/or implement improvement.
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.
Ensure the CAPA and Customer complaint investigation, procedures, and activities comply with FDA Quality System Regulations, ISO, and Medical Device Directives .
Assist in preparation of the management review meetings, QMS status overviews for management and other staff, QMS reports.
Degree level in Engineering, Biomedical or Chemistry or Civil engineering is preferred
Minimum of 3-5 years of working experience with Quality Systems in particular on the validation of the computerized systems and process validation
Knowledge of ISO Standards (13485,14971) and FDA requirements.
Willingness to travel occasionally within EU.
English & Flemish spoken to a native level is requested. 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 firstname.lastname@example.org- if you have any further questions, please do get in contact!