QA Specialist

Primary Function of Position
The position is responsible for quality management activities including but not limited to site registration quality records management local labeling management. Also responsible for managing and implementing necessary measures to comply with the Intuitive Quality Manual and related internal procedures under ISK Quality Management System (ISK QMS).  

Closely collaborate with Regulatory affairs Commercial Customer Service and SCM.  

Essential Job Duties

Regulatory compliance & QMS management

• Support internal QMS monitoring
• Follow up all post auditing activities and drives the execution of corrective action and preventive action ensuring the timely closure of CAPA/ARF actions.
• Closely communicate with regulatory agencies to seek resolutions on quality issues or formal disputes that may arise.
• Manage local IFUs archiving process and conduct regular internal labeling monitoring
• Review & approve product release return scrape preowned device report and manage the related records to comply to the local regulations ISK QMS and Global guidelines.
• Regularly train 3rd parties involved in quality activities to ensure the GSP compliance.
• Cooperate with Safety control team to assess the product complaints and reduce the product complaints
• Participate in local or global quality efficiency improvement projects.

Site registration

• Support all procedures of site registration including new site registration change management renewals after-approval administrative work precisely and efficiently including strategy set up compiling submission dossier communication with the responsible health authority/notified bodies safety stock building in cooperation with responsible functions documents archiving reporting etc.
• Support or manage on-site or desktop audits.
• Provide regulatory input to stakeholders within ISI & ISK to support business planning product stock management etc

Qualifications :

Essential Job Duties

Regulatory compliance & QMS management

• Support internal QMS monitoring
• Follow up all post auditing activities and drives the execution of corrective action and preventive action ensuring the timely closure of CAPA/ARF actions.
• Closely communicate with regulatory agencies to seek resolutions on quality issues or formal disputes that may arise.
• Manage local IFUs archiving process and conduct regular internal labeling monitoring
• Review & approve product release return scrape preowned device report and manage the related records to comply to the local regulations ISK QMS and Global guidelines.
• Regularly train 3rd parties involved in quality activities to ensure the GSP compliance.
• Cooperate with Safety control team to assess the product complaints and reduce the product complaints
• Participate in local or global quality efficiency improvement projects.

Site registration

• Support all procedures of site registration including new site registration change management renewals after-approval administrative work precisely and efficiently including strategy set up compiling submission dossier communication with the responsible health authority/notified bodies safety stock building in cooperation with responsible functions documents archiving reporting etc.
• Support or manage on-site or desktop audits.
• Provide regulatory input to stakeholders within ISI & ISK to support business planning product stock management etc

Additional Information :

Intuitive . .

.

Remote Work :

No

Employment Type :

Full-time