Job Description

社名
社名非公開

職種
品質保証、品質管理

業務内容
Lead quality initiatives and build a thriving QA function within a dynamic international team – a fantastic opportunity for experienced QA professionals!■About the companyOur client is a leading global player in the biotech industry, renowned for its commitment to innovation and high-quality products. They are dedicated to providing cutting-edge solutions in the molecular diagnostics field, fostering a collaborative and supportive work environment.■Role & ResponsibilitiesYou will be a key member of the Quality Assurance team, playing a crucial role in maintaining and improving the company's Quality Management System (QMS). You will lead projects focused on continuous improvement, collaborating closely with international teams and ensuring compliance with Japanese regulations. You will directly contribute to the smooth operation of the company’s warehouse and distribution activities, ensuring timely product releases and efficient management of labelling and regulatory compliance.■Main tasks include・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.If you are interested in this exciting opportunity, apply now.We look forward to hearing from you.#LI-Hybrid

求められる経験
■Requirements
・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.

保険
健康保険　厚生年金保険　雇用保険

休日休暇
土曜日　日曜日　祝日

給与
年収600 ～ 1,000万円

賞与
-
雇用期間
期間の定めなし

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