[Quality] Customer Quality Supervisor (Surgical Vision）

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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:

(Japanese)====================================

■職位概要

信頼性保証部 顧客品質において、法規制および社内規定（J&J Standard等）の遵守ならびに品質マネジメントシステムに基づき、日本市場における製品に関する不具合情報・品質情報（苦情を主とする品質情報）を収集し、顧客および行政に対して適切な情報提供または報告を行う。

製造元または供給業者と連携し、適切な苦情調査を実施し、顧客への調査結果の報告を行う。

■主な職務及び責務

・チームメンバーの各業務を監督し、業務遂行をリードする。

・チームの業務改善活動をリードする。

・営業部門等（Technical Service部門を含む）より収集した品質等に関する情報（苦情情報）に対し、社内規定（国内規定、J&J Standard等）に則った情報の評価を行い、製造元および供給業者における関連部門と協働し、発生原因を追究するための苦情調査を行う。

・営業部門等からの要請に応じて、品質上重要な案件または対応が困難な苦情案件について顧客対応を行い、必要に応じて顧客施設での事象確認、情報収集および関係部門との調整を実施する。また、製造元や社内関係部門と連携し、問題解決に向けた対応を推進する。

・国内における苦情の傾向を監視し、特異な傾向が見られた際には、製造元および国内品質業務運営責任者／品質保証責任者に共有し、原因調査および改善活動に参画する。

・製造業者（3rd Partyを含む）から報告を受けた原因調査結果および再発防止のための是正・予防措置（CAPA）に対する評価結果を国内品質業務運営責任者／品質保証責任者に報告し、国内における必要な措置をサポートする。

・回収／改修作業において、信頼性保証部の一員として迅速かつ円滑な作業をサポートする。

■経験及び教育

・大学卒業以上またはそれと同等の資格を有する者。

・物理学、化学、生物学、工学、情報学、金属学、電気学、機械学、薬学、医学または歯学に関する専門課程を修了した者が望ましい。

・苦情処理、品質保証、品質管理または製造管理における2年以上の経験。（医薬品または医療機器業界であれば尚可）

・法令およびQMS省令の要求事項に関する理解と実践経験。

・チームまたはプロジェクトをリードした経験があることが望ましい。

■必要な知識・スキル・能力

・ビジネスレベルの英語力（会話、読み書き）。

・PCに関する全般的なスキル。

・行政、組織および個人間における文書および口頭による優れたコミュニケーション能力。 ・高いオーナーシップを持ち、目標達成に向けて主体的かつ柔軟に行動できること。

■勤務地・出張要件

勤務地：東京本社

出張要件： 国内出張（若干） 国外出張（機会ベース）

(English)====================================

■Position Summary

Within Customer Quality, Reliability Assurance, this position is responsible for collecting and evaluating product quality information, including complaints and other quality-related information, in the Japanese market in compliance with applicable regulations, company policies (including J&J Standards), and the Quality Management System. The role provides appropriate information and reporting to customers and regulatory authorities as required.

In collaboration with manufacturers and suppliers, this position conducts complaint investigations and communicates investigation results to customers.

■Primary Duties and Responsibilities

• Supervise team members' daily activities and provide leadership to ensure effective execution of responsibilities.

• Lead continuous improvement initiatives to enhance team performance and operational efficiency.

• Evaluate quality-related information, including product complaints, collected through commercial functions and other departments (including Technical Service), in accordance with internal policies, local regulations, and J&J Standards. Collaborate with manufacturers, suppliers, and relevant stakeholders to conduct complaint investigations and determine root causes.

• Upon request from commercial functions and other stakeholders, provide support for quality-critical or complex complaint cases. This may include customer interactions, on-site visits to customer facilities, verification of reported events, information gathering, and coordination with relevant internal and external stakeholders. Work closely with manufacturers and cross-functional partners to drive issue resolution.

• Monitor complaint trends within Japan and, when unusual trends are identified, communicate findings to manufacturers and responsible quality management personnel. Participate in investigations and improvement activities as appropriate.

• Review and assess investigation results and corrective and preventive actions (CAPA) provided by manufacturers, including third-party manufacturers, and report assessment outcomes to responsible quality management personnel. Support implementation of necessary actions within Japan.

• Support product recall and field action activities as a member of the Reliability Assurance organization to ensure timely and effective execution.

■Experience and Education

• Bachelor's degree or equivalent qualification required.

• Degree in Physics, Chemistry, Biology, Engineering, Information Science, Metallurgy, Electrical Engineering, Mechanical Engineering, Pharmaceutical Sciences, Medicine, Dentistry, or a related discipline preferred.

• Minimum of two years of experience in complaint handling, quality assurance, quality control, or manufacturing operations. Experience in the pharmaceutical and/or medical device industry is preferred.

• Practical knowledge of applicable regulations and Quality Management System (QMS) requirements, with demonstrated experience applying such requirements in the workplace.

• Experience leading a team and/or project is preferred.

■Required Knowledge, Skills, and Competencies

• Business-level English communication skills, both written and verbal.

• Strong general computer skills.

• Excellent written and verbal communication skills with regulatory authorities, internal stakeholders, and external parties.

• Strong sense of ownership, with the ability to work proactively and adapt flexibly to achieve objectives.

■Location and Travel Requirements

Location: Tokyo Headquarters

Travel Requirements:

• Occasional domestic travel

• International travel as business needs require

 

 

Required Skills:

 

 

Preferred Skills:

Audit Management, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment