QA/RA Specialist at a global Medical Tech firm | Michael Page Japan の求人詳細


キービジュアル キービジュアル
更新日 2018-06-19
掲載開始日 2018-06-18

QA/RA Specialist at a global Medical Tech firm

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Michael Page Japan
企業名 会社名非公開
Michael Page Japan
メディカル/医薬/バイオ/素材/食品 - 品質管理/保証
業種 医療・福祉関連
勤務地 アジア 日本 東京都

仕事内容 * Work as a QA/RA Specialist in a renowned and growing international medical technology firm. The company offers a unparalleled opportunities for career development.



* Handling manufacturing process and manufacturing controls

* Contributing to MAH license documentation and compliance

* Assuring compliance with GQP standards and Good Manufacturing Practice (GMP) requirements

* Maintenance and administration of Quality Management System (QMS)

* Maintaining quality controls, product quality and product release processes

* In charge of documentation and liaison between government, local authorities and the company

* Handling of customer complaints, market corrections, product information, product recalls and audits

* Contribute to hosting internal and external audits

* Keeping updated on current regulations and assuring compliance with regulatory changes


* Responsibility for maintaining on-site manufacturing operations (Responsible Engineering Manager)

* Responsibility for handling quality and regulatory tasks for the company


* As a QA/RA specialist you are a tenacious deliverer with an eye for details. With responsibility for quality control and quality processes, you are well versed in Japanese medical laws and regulations.

* University degree in relevant field

* Minimum 3 years' experience from quality assurance position

* Experience from regulatory work in medical device or pharmaceutical industry

* Experience from MAH license management and compliance with local quality and regulatory requirements in Japan

* Experience from QMS maintenance

* Administrative experience

* Knowledge of Japanese medical regulations and applicable standards

※Knowledge and experience of medical software is meriting

※Experience of document management is meriting

※Experience from working in an international environment is meriting

Job Offer

* Work in a renowned medical technology company, which offers unparalleled opportunities for career and self development
* Location is in the centre of Tokyo
* Attractive salary of 6M-9M (depending on experience)

To apply online please click the 'Apply' button below. For a confidential discussion about this role please contact Petras Storpirstis on +813 6832 8690.
* Our client is medical technology company that develops software used in various core processes. The company markets its products worldwide and has subsidiaries in many countries over the world.
英語能力 ビジネス会話 (TOEIC 735-860)
日本語能力 ネイティヴレベル
年収 日本・円 600万円 〜 900万円   

QA/RA Specialist at a global Medical Tech firm