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Quality Assurance Specialist

Intuitive (Tokyo, 日本) フォロー 31日前

Contract

Company Description

会社の説明
Intuitiveでは、果たすべき使命に向けて皆で団結して取り組みます。当社は、低侵襲治療は生活をより豊かにする治療であると考えています。独創性とインテリジェントなテクノロジーを通じて医師の潜在能力を広げ、制約なく治療できるようにします。
私たちは、ロボット支援手術におけるパイオニアであり市場リーダーとして、インクルーシブで多様性のあるチームの育成に努め、変化を生み出すことに尽力しています。25年以上にわたり、世界中の病院や医療チームと協力して、ヘルスケアのいくつかの最も困難な課題の解決を支援し、可能なことを前に進めてきました。
Intuitiveは、さまざまなバックグラウンドを持つ優秀な人材の努力によって成り立っています。優れたアイデアはどこからでも得られると信じ、私たちは、思考の多様性と相互の尊重に根差したインクルーシブな文化の醸成に努めます。また、包摂性（インクルージョン）を持ってチームメンバーを指導し、ありのままの自分で最高の仕事ができるよう力づけます。
変化を生み出すことを望む情熱的な人々が、当社の文化の原動力となっています。私たちのチームメンバーは、誠実さを重視し、高い学習能力と物事をやり遂げるエネルギーを持ち、当社が新しい考え方ができるよう多様な実体験をもたらします。私たちは、チームメンバーが引き続き当社の使命を遂行し、最大限の可能性を実現できるよう、積極的に投資して彼らの長期的な成長をサポートします。
医療従事者と患者さんのグローバルなコミュニティを目指して大きく躍進しようと尽力しているチームの一員になってください。一緒に、低侵襲治療の向上に取り組みましょう。

Job Description

Primary Function of Position:

Manage and implement required actions to maintain existing product lines and to solve any product quality issues occurred in Japanese market.
Take timely and appropriate quality management actions and executing communications with government and internal / external customers.

Roles and Responsibilities:

This position has mainly following responsibilities and authorities to timely deliver effective and safety products in Japanese market, to reduce customer complaint/malfunction, and to improve product quality:

Lead risk management team and implement risk management activities from the viewpoint of product and subcontractors / suppliers in cooperation with related functions.
Assess change notifications from headquarters and manufacturing sites, and implement necessary actions in cooperation with related functions.
Evaluate customer complaints from the viewpoint of product quality, report to ISI and manufacturing sites, and evaluate the analysis result in cooperation with Safety Control team. Furthermore, create customer letters, and communicate to customers to solve the quality issue with Marketing, Sales, Field Service and Safety Control teams.
Completing quality issues by working with regulatory agencies, customers and related functions.
Collaborate with Product Quality team and Safety Control team to reduce customer complaints from the viewpoint of product.
Involve in implementation of a field action like a recall.
Collaborate with QRC team to maintain Quality Management System.
Work related to product realization (control DMRs and materials for released products etc.)
Operate product release (IQC, labeling instructions, and market release assessment etc.)
Manage non-conforming products (rework, concession, and hold etc.)
Work related to data analysis and CAPA.

Qualifications

Skill/Job Requirements:

Minimum Education:
- Bachelor or higher degree (Preferred: Physics, Chemistry, Biology, Material Engineering, Electrical Engineering, Mechanical Engineering or Pharmacology)
Background:
- Minimum 3 years experience in Pharmaceutical/Medical Device/IVD industries
  OR
- Minimum 3 years experience related to Quality in any manufacturing industries
Skill / Experience:
- Must:
  - Good interpersonal/communication skill to work well with cross-functional teams
  - Analytical mindset and ability to see the big picture
  - Project management skill
  - Logical thinking skill
  - Strong willing to achieve goals
  - Verbal and written communication in English and Japanese
  - Knowledge of basic Quality Management System (e.g. ISO 9001) / Quality Assurance / Quality Control methodology
  - Basic PC skill (e.g. Microsoft Word /Excel / Powerpoint)
- Preferred:
  - Knowledge of J-PMD Act, relevant regulations, ISO 13485 and ISO 14971
  - Experience of complaint handling and/or complaint product investigation
  - Experience of using Oracle Agile PLM, SAP, Trackwise, and/or HP ALM