[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:

Quality & Regulatory Compliance in Johnson and Johnson K.K. is recruiting for Surgery QRC Staff, located in Tokyo HQ office.

Key Responsibilities

Ensure compliance with applicable domestic and international regulations, standards, and quality requirements. Develop and maintain an effective Quality Management System (QMS) that addresses the needs of internal stakeholders, and execute quality system activities in accordance with established procedures, including document control, change management, and business license management.

In addition, develop and implement initiatives that deliver value to both internal stakeholders and customers through the QMS. Proactively identify and understand customer needs, business requirements, and organizational changes, while building strong and trusted relationships with stakeholders, including global partners, to establish simpler, more efficient, and reliable QMS processes.

Experience and Skills:

Required:

Knowledge and practical experience of laws and QMS ministerial requirements

Proactive approach/ Able to appropriately demonstrate unique initiatives

Ability to work both independently and in collaboration with others.

Proactive approach/uses own initiative appropriately.

Logical thinking, decision making, problem-solving skills, positive thinking, and attitude to learn new things.

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

Native verbal and written communication skills in Japanese.

Preferred:

At least 3 years of experience in Quality Assurance or Quality System function within the regulated Medical Device or Pharmaceutical industry

English skill in business level.

Experience in global/cross culture 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).

Johnson and Johnson K.K.のMedTech, Quality Assurance部門におけるQuality &　Regulatory Compliance Surgery QRCスタッフを募集します。

主要な責務

国内外の規制・基準要件へ準拠したコンプライアンスを遵守し、社内ステークホルダーのニーズを考慮した品質マネジメントシステムの構築や、品質システム手順書に基づく実施業務（文書管理、変更管理、業態管理など）を行うとともに、社内ステークホルダー及び顧客に対し品質マネジメントシステムを通して価値を届けることの施策の策定、実行を行う。また、顧客・ビジネスのニーズ・変化を的確に把握し、各ステークホルダー（海外含む）との良好な信頼関係を築き、よりシンプルで効率的かつ確実なQMS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、ポジティブ思考、新しいことを学ぶ姿勢

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

日本語での口頭および文書による優れたコミュニケーション能力

Preferred:

3 年以上の医療機器又は医薬品業界における品質保証又品質マネジメントシステムの構築・維持・管理に関連する業務経験

ビジネスレベルの英語力

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