QA Specialist

Hologic · Tokyo

Participate and support internal and/or external audits, inspections, or surveillance to demonstrate compliance with the regulations or standards such as QMS Ordinances No.169, ISO13485, and MDSAP audit requirements.
Organize and review processes, Quality Manual, Standard Operation Procedures, Working Instructions, QMS records, and other documents to assure regulatory compliances.
Evaluate necessity of action (CAPA, regulatory reporting and/or field action, improvement) from identified non-conformance, non-conformity and complaint. In addition, managing it.
Other improvements in QMS and Vigilance processes as MAH to adopt regulatory requirement, corporate polices and environmental change.
Participate in cross-functional team for new product introduction to provide expertise in quality and safety of Medical Devices, IVDs, and other products.

As a member of RAQA team in Hologic Japan, Quality and PMS Specialist (or Sr. Specialist) is responsible for working as a specialist to •Maintain & improve quality management system in compliance with relevant standards, regulations and harmonize with corporate policies. •Coordinate with local and global stakeholders to provide communication on post-market feedback in the region to maintain reliable post-marketing vigilance and its reporting system. •Assist in Quality Control & Assurance operation throughout the organization by assuring all products and processes to maintain and/or improve compliance.

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