QA Specialist

Primary Function of Position ****

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

Intuitive는 고용 기회 균등 고용주입니다. 당사는 인종, 성별, 임신 여부, 성적 지향, 성 정체성, 출신 국가, 피부색, 연령, 종교, 국가 보훈 대상자, 장애 여부, 유전 정보 또는 연방, 주 또는 현지 관련 법률에 따라 보호받는 기타 모든 지위에 관계없이 자격을 갖춘 모든 지원자 및 직원에게 동등한 고용 기회를 제공하며 모든 유형의 차별과 괴롭힘을 금지합니다.

당사는 기회 균등법에 따라 범죄 및 유죄 판결 기록이 있는 고용 자격을 갖춘 지원자를 고려할 것입니다.