(Quality) QA Specialist, Quality Systems (MedTech)

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 .
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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-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-、 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-ズを的確に把握し、 各事業部、 3 rd p ar t y 、 ステ-クホルダ-(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-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-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-ム リ-ダ-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-/グロ-バル環境での経験

• IT /デジタル リテラシ-

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