品質保証スタッフ
Core
Support the operation of a Quality Management System (QMS) based on the Pharmaceutical Affairs Act and ISO 13485 for medical device manufacturing and sales.
Role type
Quality Assurance Staff (QMS Operations)
Builds
Medical device quality management systems and documentation
Domain
Medical devices / Healthcare manufacturing
Deliverable
dashboards & analysis
Required skills
PC skills (Word, Excel, PowerPoint, Outlook), Communication, Data analysis, Report creation
Preferred skills
Medical device/pharmaceutical industry experience, QMS knowledge (Pharmaceutical Affairs Act, ISO 13485), English reading/writing
Responsibilities
Create and maintain QMS-related documents (product standards, package inserts), Operate and manage QMS systems, Collect and analyze QMS data, Support QMS processes (training, CAPA)
Seniority
Entry to Mid-level