Quality Assurance Specialist

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募集要項

会社概要

海外で製造された顕微鏡やその周辺機器を、日本国内で輸入・販売している企業です。ドイツを代表する精密機器企業の系譜を持ち、最高級品質の製品を提供しています。1990年に複数の企業が統合して誕生した現在の企業は、ヨーロッパを代表する理化学機器メーカーです。顕微鏡やその関連機器を通じて、ユーザーの生命科学や産業分野における高度な観察、測定、分析ニーズに対応し、最適なシステムソリューションを提供しています。

業務内容

Main responsibilities:
・Both IVD and medical device MAH Quality responsible person(Hinseki).・Both IVD and medical device MAH manufacturing manager (Seizou Sekininsha).・Lead and support for collaborating with BU and SU stakeholders to manage quality issues including support for the administration of fileld actions (Recall) and reporting in complaint system.・To update QMS documents based on local regulation modification/new release.・To lead regular internal QMS meeting and management review meeting.・To support all related LBS license (MAH IVD/medical device, poisonous substance import,medical device maintanance etc.)・To support medical writing regarding both IVD and medical device STED.・To support PMDA consultation document preparation and preparation for answers of queries from PMDA.

応募条件

Minimum requirements:
・Minimum of 7 years’ work experience in medical or life science market.・>5 years People Management experience (Preferred).・Pharmaceutical license holder (Goverment certified Pharmacist License).・Effective communication skills in English and a client service orientation.・Excellent cross functional communication skills.・Strong business acumen in understanding commercial aspect of healthcare business.・Organized individual with strong self and project management disciplines, including the ability to lead, facilitate, influence and organize across groups and according to timelines.
Preferred qualifications:
・Knowledge of MS Excel, Word, PowerPoint for business presentation and knowledge of PMDA DTD system will be highly advantageous.

給与

800 - 1100 万円

勤務地

東京