Senior QA Specialist
Core
Ensures compliance with Japanese medical device and IVD regulations and maintains the Quality Management System (QMS) for Abbott's diagnostic products in Japan.
Role type
Senior Quality Specialist (Commercial Quality & Compliance)
Builds
Quality Management System (QMS) for In Vitro Diagnostics (IVD) and Medical Device products
Domain
Healthcare / Medical Devices / In Vitro Diagnostics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Management System (QMS) maintenance, nonconformance management, root cause analysis, CAPA implementation, change control, quality risk management (ISO 14971), document control, complaint handling, post-market surveillance, supplier quality management, audit support (internal/external/regulatory), logistics quality oversight
Preferred skills
Pharmacist License, experience in Medical Devices and/or In Vitro Diagnostics (IVD)
Technologies
QMS Ministerial Ordinance No. 169, ISO 14971
Responsibilities
Support implementation and maintenance of Commercial QMS for Medical Device and IVD products; Lead investigations for nonconformances, deviations, and complaints; Conduct root cause analyses and drive CAPA; Support internal, supplier, and regulatory audits (PMDA, Notified Body); Manage quality documentation and records; Oversee distribution and logistics quality compliance; Perform supplier quality evaluations and audits
Seniority
Senior, hands-on IC