[Quality] Manager Quality Assurance [Shockwave]

Tokyo - Japan

Monthly Salary: Not Disclosed

Posted on: 10 hours ago

Vacancies: 1 Vacancy

Job Summary

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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:

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 companys 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 inmedical 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

Required Experience:

Manager

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 companys 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 inmedical 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:

Required Experience:

Manager

Key Skills

Quality Assurance
FDA Regulations
Food Industry
Food Safety Experience
ISO 9001
Quality Systems
Food Processing
Quality Control
Quality Management
QA/QC
Selenium
HACCP

Apply Now

About Company

Johnson & Johnson

About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more

View Profile View Profile

AI AutoApply

Apply to 100+ jobs with one click