[Quality] QA Specialist, Quality Systems [MedTech]

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Customer/Commercial Quality

Job Category:

Professional

All Job Posting Locations:

Chiyoda, Tokyo, Japan

Job Description:

Job Description

SCOPE OF THE ROLE AND BASIC PURPOSE

Key Responsibilities

In the   EP/NV   Quality assurance ,   Quality &   Regulatory Compliance, based on compliance with laws and regulations and internal regulations (J & J Standard, etc.) and the quality management system, establish the system and manage and supervise the overall QMS system, including the management of   NC/ CAPA,   Internal Audit management,   Quality   system   management review, 　Record management   and audit response. In addition, he/she shall accurately grasp the needs of customers and businesses,   build   a   good, trusted   relationship   with each FC,   3   rd   party, and stakeholders (including overseas), and establish more efficient QMS business processes.

Experience and Skills:

Required:

Knowledge and practical experience of   laws   and QMS ministerial requirements

Proactive approach/   Able to appropriately demonstrate unique initiatives

Logical Thinking, Decision Making, and Problem-Solving Skills

Has a strong commitment to achieving goals and a flexible ability to execute.

Excellent written and oral communication skills among   government , 3   rd   parties, organizations, and individuals.

Business level English proficiency (Conversation, reading and writing)

Project and Team Leadership

Ability to multitask.

Preferred:

At least 3 years of experience in   quality system/ quality assurance/quality control and safety management. (This is acceptable if you are in the pharmaceutical or medical device industry)

Internal/External Audit Implementation and Response Experience (QMS Auditor License   Holder )

Experience in the cross-culture/global environment

IT/ Digital   literacy

Education:

Bachelor's degree or educational equivalent (Health science or other directly related field or equivalent combination of education is preferred).

主要な責務

EP/NV   Quality   assurance 　Quality &   Regulatory   Compliance   において、法規制や社内規定(J&J Standard等)の遵守及び品質マネジメントシステム （QMS） に 基づ き、日本の市場における製品 及びサービス に関する Nonconformance / CAPA 管理 、 内部監査の管理 、 マネジメントレビュー、 品質記録管理、 監査対応 などQMS全般の体制構築及び管理 監督 を行う。   また、 顧客・ビジネスのニーズを的確に把握し、 各事業部、 3 rd   p ar t y 、 ステークホルダー（海外含む）との良好な信頼関係を築き、より効率的 な QMSの 業務プロセスを確立する。

経験とスキル：

必須：

法令及びQMS省令の要求事項の 知識 と実践経験

プロアクティブなアプローチ /独自のイニシアチブを適切に 発揮できる

論理的思考、意思決定、問題解決スキル

目標達成に対する強いコミットメント及び柔軟性のある実行力を有する。

行政、 3 rd   p ar t y 、 組織及び個人間における文書及び口頭による優れたコミュニケーション能力。

ビジネスレベルの英語 力 （会話、読み書き）

プロジェクト およびチーム リーダーシップ

マルチタスク遂行能力

Preferable ：

品質システム・ 品質保証・品質管理または安全管理における3年以上の経験。（医薬品または医療機器業界であれば尚可）

Internal/External監査実施及び対応経験( QMS Audit o r License Holder)

クロスカルチャー/グローバル環境での経験

IT /デジタル リテラシー

Education:

大学卒業   ( 大学卒業以上またはそれと同等の資格を有する者 ）

Required Skills:

Preferred Skills:

Business Behavior, Compliance Management, Continuous Improvement, Data Analysis, Data Compilation, Detail-Oriented, Execution Focus, Goal Attainment, Internal Controls, Issue Escalation, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report Writing