Quality Assurance Specialist
Core
Lead risk management, assess change notifications, evaluate customer complaints, and manage product quality issues for the Japanese market to ensure safety and reduce malfunctions.
Role type
Quality Assurance Specialist (Medical Device/Pharmaceutical)
Builds
Safety-compliant medical devices and pharmaceutical products for the Japanese market
Domain
Medical Device / Pharmaceutical / IVD
Deliverable
client delivery
Required skills
Risk management, Change notification assessment, Customer complaint evaluation, Regulatory agency coordination, CAPA implementation, Non-conforming product management, Data analysis, Quality Management System knowledge (ISO 9001)
Preferred skills
J-PMD Act knowledge, ISO 13485 knowledge, ISO 14971 knowledge, Complaint handling experience, Product investigation experience, Oracle Agile PLM usage, SAP usage, Trackwise usage, HP ALM usage
Technologies
Oracle Agile PLM, SAP, Trackwise, HP ALM
Responsibilities
Lead risk management team and implement activities, Assess change notifications from headquarters and manufacturing sites, Evaluate customer complaints and report to ISI and manufacturing sites, Create customer letters and communicate to solve quality issues, Complete quality issues by working with regulatory agencies, Collaborate on field actions like recalls, Maintain Quality Management System, Operate product release (IQC, labeling, market release assessment), Manage non-conforming products (rework, concession, hold), Work on data analysis and CAPA
Seniority
Mid-level, hands-on IC