QA senior specialist

• Lead quality initiatives and build a thriving QA function within a dynamic international team
• Lead local project implementations and contribute to larger global projects
• Maintain and improve the company's QMS, implementing local solutions as needed
• Manage quality systems such as document control, utilizing global eQMS and eDMS/eTMS systems
• Support internal, external (regulatory/Notified Body), and supplier audits
• Collaborate with the Global CAPA team to resolve customer issues related to molecular diagnostic (MDx) products
• Partner with the Warehouse/3PL team to ensure efficient operations, including product release and re-labeling
• Handle quality-related inquiries

• 3+ years of experience in Quality Assurance within a regulated IVD/MD company
• Experience working in an international organization
• Experience supporting audits with Competent Authorities/Notified Bodies
• Excellent written and spoken English
• Strong understanding of Japanese regulations for Molecular Diagnostics (IVDs) and Devices
• Proven ability to lead projects and drive continuous improvement initiatives
• Experience with eQMS and eDMS/eTMS systems
• Strong collaboration and communication skills
• Problem-solving and analytical skills
• Experience working with 3PLs or warehouse management is a plus

Experience working with 3PLs or warehouse management

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