Sr. Quality Operation Analyst
Core
Ensures compliance with quality assurance processes and regulatory standards for genomic technology products and services.
Role type
Senior Quality Operation Analyst
Builds
Compliance frameworks, risk assessments, and quality documentation for genomic health products
Domain
Genomics / Medical Devices / In Vitro Diagnostics
Required skills
Quality Management Systems (QMS), regulatory compliance, risk assessment, internal controls, audit execution, Japanese (native), English (business level), stakeholder negotiation, problem-solving
Preferred skills
Pharmacist license, GVP self-inspection, QMS audit experience, Computerized Document Management Systems, Safety Controller experience, Foreign Manufacturing site management
Technologies
Microsoft Excel, Word, PowerPoint, Access, Outlook, Computerized Document Management Systems
Responsibilities
Monitor conformance to quality standards, evaluate internal controls and risks, facilitate internal training on QA requirements, perform audits and risk assessments, update IFU and safety notification letters, manage recall actions under PMD Act
Seniority
Senior, hands-on IC
