Manager, Global Quality Management System/大手日系医療機器メーカー

求人詳細

■Job Description
The Senior Manager, Global Quality Management System is responsible for the global Quality Management Review. In this role, you will plan, coordinate, prepare and execute the global Quality Management Review at scheduled intervals and additional reviews as required. This will include following up on the management review to close identified actions and lead continuous improvement and completing all reports.
This role will partner close with other Quality and cross-functional leaders at site and global levels to assess the impact of changes to the Quality Management System and enable a timely completion of inputs to the QualityManagement Review

■Job Duties
- Oversee the management of the Quality Management Review lifecycle including:
- Plans the global Quality Management Review schedule and aligning with site/QMS level reviews
- Coordinates content for Quality Management Review across site and global level including data from site level reviews.
- Prepares content for each Quality Management Review. Ø Initiates and/or hosts a review of data prior to scheduled meetings.
- Completes reports as an output of Quality Management Review.
- Follow-up and tracking of outputs and actions for completion.
- Fosters a culture of continuous improvement by identifying areas to improve, driving continuous improvement initiatives, and utilizing problem solving methodologies.
- Ensures functional groups adhere to the company’s Management Review procedures.
- Effective Subject Matter Expert role for Management Review and tools in scope.
- Establishes metrics to evaluate QMR performance.
- Communicates with each site to promote and select escalated data for the global Quality Management Review.
- Participates in Quality initiatives as a cross functional contributor.
- Demonstrates operational excellence and ensures quality in all deliverables.
- Supports CAPA investigations & audit requests (internal & external).
- Supports audits as a Subject Matter Expert for Management Review, as required.
- All other duties as assigned.

【勤務時間】
8：45～17：30 （休憩：昼45分）
　標準労働時間8時間　
※時短勤務制度あり
※テレワーク勤務あり・時間外労働あり
〈ご参考〉業務の状況等により変更となる可能性がございます
・在宅勤務：原則在宅勤務（必要に応じ出社）

こんな方を求めています

経験・スキル

■Required:
- BS Degree in science or demonstrated equivalent professional experience.
- Minimum of 10 years Quality Management System experience required with demonstrated experienceimproving and/or maintaining quality management system (medical device is preferred) and preparingQuality Management Reviews.
- Minimum of 5 years of experience required in data analysis, trending and presenting data in a manner todrive informed decision making.
- Excellent understanding and working knowledge of appropriate global regulations, requirements andstandards such as ISO 13485:2016, ISO 9001:2015 and FDA Quality System Regulation
- Ability to participate as a functional leader of a self-directed work organization and utilize the resources ofthe team.
- Having the global viewpoint to establish and maintain the QMS compiled with global requirements.
- Travel to other company (regional) facilities may be required, up to 10%
- Travel to other facilities/locations may be required, up to 10%

■Preferred:
- Excellent working knowledge of Quality Management Review.
- Strong attention to detail.
- Ability to operate efficiently, proactively and effectively in a fast-paced environment.
- Strong verbal and written communication skills, with the ability to interact with all levels of the organization.
- Strong stakeholder management and ability to influence and coach others.

学歴

大学卒業以上

募集要項

職種

統計解析、データマネジメント

給与

年収 900 〜 1,500万円

賞与

-

雇用形態

正社員

雇用期間

期間の定めなし

試用期間

有り

就業時間

08:45～17:30

休日休暇

日曜日,土曜日,祝日
・年間休日：129日

保険

健康保険,厚生年金保険,雇用保険,労災保険

待遇・福利厚生

拠出型企業年金、選択型福利厚生、従業員持株会制度、財形貯蓄制度など

受動喫煙防止措置

敷地内禁煙

特長

上場企業, 転勤なし, 土日祝休み, 年間休日120日以上, 月平均残業時間20時間以内

業種

医療機器・医療品関連

※詳細はお仕事のご紹介時にお伝えします