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QAシニアマネージャー  
■ポジション情報
NO JOB003105
業務内容 [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).
勤務地 東京都
経験・知識 ■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
■企業情報
会社名 外資系医療機器メーカー
企業の特徴 米国に本社を置く世界有数の医療機器企業であり、世界各国で事業を展開しています。
特にインターベンション(低侵襲治療)におけるパイオニアであり、リーディングカンパニーです。
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