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Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Chuo-ku, Tokyo, Japan

Job Description:

Essential Job Function:

• Responsible for maintaining the Quality Management System (QMS) in compliance with MHLW ordinance No 169 (QMS ordinance) and other regulatory requirements.

• Ensure Quality Management System procedures are established and maintained in compliance to International, National and Local regulatory requirements and company’s policies.

Identify changes to relevant regulatory requirements and industry standards

• Undertake gap assessment activities to newer regulatory requirements

• Work cross functionally to address the identified system gaps and implement changes

• Train the organization to ensure the new requirements are communicated internally

• Manage the NCR process

Administer and manage the NCR process and maintain overall compliance to relevant procedures

• Collect and analyze data from various processes (NCRs) for periodic reviews

• Coordinate with cross functional team members to collect relevant data and compile presentation for the reviews

• Identify opportunities for improvement

• Present the information at the periodic reviews Monitor and trend metrics

• Identify and drive Quality Management System continuous improvement activities

• Supplier Management

Define and implement processes which meet regulatory requirements pertaining to the selection, evaluation, and monitoring of suppliers

• Create and/or maintain procedures to ensure that the organization complies with applicable regulatory standards

• Identify supplier risks and work with cross-functional teams to prevent and/or resolve issues which could interrupt business continuity

• Communicate critical issues to upper management and escalate accordingly

• Oversee and manage the execution of Supplier Quality responsibilities such as Supplier Audits, Supplier Qualifications.

• Schedule, plan and implement an effective internal and external Audit program.

• Manage Document Control and Training system.

• Other relevant duties as assigned

• undefined

Requirements:

BS degree in a related discipline with 10+ years’ experience in medical device quality systems and compliance role

2 years of managerial experience or equivalent, relevant experience

Strong understanding of PMD Act and other International medical device regulations

Excellent written and verbal communication skills

Experience in supporting Regulatory Submissions:

Strong front room audit experience with an ability to effectively present and defend quality systems under your responsibility and management

Proficiency in using Statistics, data compilation, analysis, presentation is preferred

Project Management experience and excellent organizational skills is preferred

Remains current with regulatory changes through industry publications, seminars, participation in trade organizations, and government meetings

Responsible for coaching, training and development of subordinates

Identifies and manages continuous improvement projects

· Ability to work in a fast-paced environment while managing multiple priorities

· Operate as a team and/or independently while demonstrating flexibility to changing requirements

Essential Job Function

• 厚生労働省令第169号(QMS条例)およびその他の規制要件に準拠した品質管理システム(QMS)の維持を担当する。

品質管理システムの手順が、国際、国内、および地域の規制要件および会社のポリシーに準拠して確立され、維持されていることを確認する。

関連する規制要件および業界標準に対する変更を特定する

新しい規制要件に対するギャップ評価活動を実施する

特定されたシステムギャップに対処し、変更を実施するために、部門を超えて作業する

新しい要件が社内に伝達されるように組織をトレーニングする

NCRプロセス管理

NCRプロセスの管理と管理を行い、関連する手順への全体的なコンプライアンスを維持する

定期的なレビューのためにさまざまなプロセス（NCR）からデータを収集および分析する

部門横断的なチームと調整する メンバーが関連データを収集し、レビュー用のプレゼンテーションを作成する

改善の必要性を特定する

定期的なレビューで情報を提示するモニタおよびトレンドメトリック

品質管理システムの継続的改善活動を特定し、推進する

サプライヤー管理

選択、評価、 サプライヤーの監視

組織が適用される規制基準に準拠していることを確認するための手順を作成および/または維持する

サプライヤーのリスクを特定し、部門横断チームと協力して、ビジネス継続性を妨げる可能性のある問題の抑止および/または解決する

重要な問題を上層部に伝え、それに応じてエスカレーションする

サプライヤー監査、サプライヤー資格などのサプライヤー品質責任の実行を監督および管理する。

効果的な内部および外部監査プログラムをスケジュールし、計画し、実施する。

文書管理およびトレーニングの管理。

割り当てられたその他の関連業務

Required Skills:

Preferred Skills:

Business Alignment, Coaching, Collaborating, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Good Manufacturing Practices (GMP), ISO 9001, Process Improvements, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Regulatory Environment, Standard Operating Procedure (SOP), Tactical Thinking, Technical Credibility