正社員

低侵襲パイオニアメーカー Sr Manager, Quality Assurance

勤務地
東京都 / 新宿区
給与
年収900万円〜1,350万円

こんな仕事です

[Key responsibility]
The Quality Manager is responsible for designing, planning, coordinating and executing projects oriented towards quality improvement in the site´s manufacturing processes. Provides support to Process Quality and Quality Engineering areas management. Establishes and maintains Quality Management systems that meet regulatory requirements, corporate policies, internal policies and business needs. Additionally, he/she is responsible for planning and supervising In Process Quality Engineers functions and activities.
Coordinate Quality Engineering and In Process Quality Engineering areas engineers' functions and activities.
Provide support to new products/process transfer projects; review risk analysis (PFMEA) for the different processes.
Plan, coordinate and execute projects oriented towards in process defects prevention.
Design and implement process control strategies.
Facilitate and support the Quality Control supervision function through Quality Engineers and Quality Supervisors.
Review and/or approval of documents, investigations, extensions or another regulatory figure within the company´s quality system, as an alternate representative of Quality Management.
Provide technical support to the In Process Quality area and to other departments.
Deliver training related to quality technologies.
Coordinate with Corporation the implementation of projects related to the In Process Quality area.
Create new procedures on In Process Quality and/or improve the existing in order to facilitate and assure regulatory compliance.
Responsible for acting as Subject Expert Matter (SME) of the following chapters of the company´s quality system: 820.70 Production and Process Controls, 820.75 Process Validation, 820.60 Identification, 820.65 Traceability, 820.72 Inspection, measuring and test equipment, 820.90 Non-conforming product, 820.80 Receiving, in-process and finished device acceptance, 820.100 CAPA.
Participate as a core team member in the new products transfer process, representing Quality Assurance areas.
May act as NCEP System administrator for the area: tracking and keeping NCEP investigations related to the area closed; area MRB administrator; area NCEP owner; perform continuous improvements in NCEPs for the area; coordinate with other NCEP administrators on actions executes and the impact on other areas.
May provide support to the Quality Director in his/her responsibilities. Authorized to sign as the Quality Director designee or representative in his/her absence or as required.
Participate in the PIR (Product Inquiry Report) process, assuring: diligent execution of activities related to the PIR, PIR assessment in the eCAPA system, PIR execution, and appropriate process communication to Corporation. May act as the Quality Director (Head of Quality) designee in PIR process activities.
May provide guidance and supervision to process validation areas, software validation and design assurance.
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
For those individuals that supervise others, the following statements are applicable:
Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
Establishes and promotes a work environment that supports the Quality Policy and Quality System.
lead a group or team of employees in the achievement of organizational goals. Guide, coach, direct, and develop direct reports, and if applicable, drive those practices throughout their organization.
Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
May direct and control the activities and budget of one or more functional areas, divisions, product groups, projects/programs and/or operations.
Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements).
勤務時間
<標準的な労働時間>
9:00~17:30 (所定労働時間7.5時間)
休憩時間:60分
時間外労働有無:有
<労働時間区分>
事業場外みなし労働時間制
みなし労働時間/日:7時間30分
<その他就業時間補足>
休憩:60分
雇用形態
正社員
<雇用形態補足>
補足事項なし
<試用期間>
6ヶ月
補足事項なし
給与
<予定年収>
600万円~800万円
<月給>
300,000円~
基本給:300,000円~
<賃金形態>
月給制
補足事項なし
<昇給有無>

<給与補足>
※上記は、セールスインセンティブのターゲット金額を含めた理論年収となります。セールスインセンティブは個人業績により算定されます。
※具体的な年収金額については能力・経験等を考慮して決定・提示いたします。
※別途、勤務状況に応じた手当があります。
予定年収はあくまでも目安の金額であり、選考を通じて上下する可能性があります。
月給は固定手当を含めた表記です。
待遇・福利厚生
通勤手当、健康保険、厚生年金保険、雇用保険、労災保険、退職金制度
<待遇・福利厚生補足>
通勤手当:社用車(リース)支給/プライベート使用可
社会保険:補足事項なし
退職金制度:勤続3年以上(定年:65歳)
<教育制度・資格補助補足>
■各種トレーニング・人材開発プログラム、社内公募制度、目標管理評価制度、昇格制度
<その他補足>
■コア・ベネフィット・プラン:入院時医療費補助、長期収入サポート保険、定期健康診断(35歳以上は日帰り人間ドック)、自己啓発支援制度(上限10万円/年)、社員持ち株会、各種祝い金、ベネフィット・ステーション
■フレックス・ベネフィット・プラン:上乗せ保険、上乗せ自己啓発、スポーツクラブ費用、自宅用パソコン購入補助、眼鏡購入補助、演劇・コンサート・映画鑑賞費用補助など
※両方とも、年間10万円(7月1日以降入社者は当該年度のみ5万円)のクレジットポイントで選択できる選択型福利厚生
休日・休暇
完全週休2日制(かつ土日祝日)
有給休暇10日~20日
休日日数124日
夏季休暇(5日)、年末年始休暇(12/29-1/4)、傷病休暇(5日)、永年勤続休暇(勤続5年ごとに5日)など

募集要項

  • 雇用形態
    正社員
  • 応募条件
    ・医療機器(Class3/ Class4)の品質保証(QMS)経験5年以上
    ・2年以上のPeople management経験(正社員の部下の育成・評価に責任をもったことがあること)
    ・Business level English
  • 勤務地
    東京都 / 新宿区
  • 給与
    年収900万円〜1,350万円
詳細を見る(外部サイト) アルファサーチ株式会社

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