QA Specialist
QA Specialist
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
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 afterapproval 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 onsite or desktop audits.
- Provide regulatory input to stakeholders within ISI & ISK to support business planning product stock management etc
Qualifications :
Required Skills and Experience
- Preferred >3 years of relevant RAQA experiences in the medical device industry.
- Knowledge of Korean Medical Device Act & related regulations/guidelines and ISO13485
- Preferred experiences in supporting GMP onsite audit on foreign sites.
- Excellent verbal and written communication both in English and Korean & interpersonal skill to work well with crossfunctional teams
- Ability to foresee regulatory challenges and develop critical concepts and methodologies to overcome these.
- Ability to work in a fastpaced environment and handle multiple projects simultaneously
- Ability to distill complexity and provide clear and actionable direction.
- Orientation for work result details with emphasis on accuracy and completeness
Required Education and Training
- Bachelors degree in science engineering medical engineering or related
- Indepth knowledge of Korean medical device act & regulations ISO13485
Preferred Skills and Experience
- Experience in SAP TrackWise
Additional Information :
Intuitive . .
.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
