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Job ID : 1446060 Date Updated : May 13th, 2024
薬事申請のご経験のある方は歓迎です。

プロセスエンジニア マネージャー

Hiring Company 非公開
Location Kanagawa Prefecture
Job Type Permanent Full-time
Salary 7 million yen ~ 9 million yen

Job Description

【求人No NJB2113963】
140年以上の歴史を持つシグニア補聴器は、急速な高齢化が進む日本において、補聴器業界のマーケッリーダーとして、聞こえに悩みを抱えている方々やそのご家族の QOL 向上に貢献しています。革新的な製品で業界をリードする当社にて、グローバルチームと連携し、業務品質改善、機器・設備・ソフトウェアの導入・メンテナンスの業務を行っていただきます。聴力に悩む方々のよりよい未来を創出することに貢献したい方を募集します。


職務内容
●Communication with AMC and HQ Operation(40%)
Daily communication in Camstar
Weekly Quality meeting
Operation issue (shipment TAT Kick out rate transfer time)
Complaint of Quality for special cases
Maintenance of system (Camstar 3shape)
Monthly 45days of AMC return report (raw data chart for return rate)
Weekly AMC quality report (return reason order history modeler’s comment)

●Support overall Operation Director’s tasks(50%)
Quality TAT Model Capex etc (whenever production manager need specific data.)
Process of other affiliate
New function of system software
For all of new project (Set up 3D printing room etc)
Check Production part timer’s service record and report production manager
Translate and update global ECI template
Report new global information
Update IPL template and asked signature for Producton manager Marketing manager QA/QA manager and report it to global before new product launch.

●Purchase repair machine between overseas(10%)
Request for machine Repair procurement
(request the repair to vendor and have communication)
Ask a quotation for PR
Approve PR as T3 in production
Control production payment case and have communication with Finance team
Ask tax Invoice to vendor and pass to Finance team
Request for quotation (overseas purchase)

●ERP update/resolve issue (infor/Camstar)
Rollout for new function of Camstar InforLN with SMI IT (Support translate option code)
Proceed system test before we use new function or new version of sytem
Give a training colleagues for new information
Request for access right for colleagues

●Software update resolve issue/training (3shape/Cambrdige/Netfaff/Hicoss/Connexx)
Installation software
Trouble shooting for software and ERP system.
(Camstar InforLN 3shape/Cambrdige/Netfaff/Hicoss/Connexx)
Give a training colleagues for new information
Update manual

●Documentation (Government Quality audit/Global Quality audit)
Update Work Instruction/SOP/Validation report in Production
Check the Calibration for all of machine tool
Request the calibration to vendor and have communication
Update the machine list monthly and report to production manager
Prepare GMP audit

●License(Yearly)
Update license for system with global (SM SD Netfabb Cambridge)

General Requirements

Minimum Experience Level No experience
Career Level Mid Career
Minimum English Level Business Level
Minimum Japanese Level Native
Minimum Education Level Bachelor's Degree
Visa Status Permission to work in Japan required

Required Skills

必要な能力・経験・資格 ビジネスレベルの英語力 エンジニア関連もしくは製造関係の経験 3年以上 )があれば尚可 目標達成への コミットメント コミュニケーション能力

Job Location

  • Kanagawa Prefecture

Work Conditions

Job Type Permanent Full-time
Salary 7 million yen ~ 9 million yen
Work Hours 09:00 ~ 18:00
Holidays 【有給休暇】初年度 10日 1か月目から 【休日】完全週休二日制 土 日 祝日 GW 年末年始 有給休暇:初年度最大 10 日…
Industry Medical Device

Job Category

  • Medical, Pharmaceutical and Healthcare > Patent Specialist, Academic
  • Chemical, Food and Materials Technology > Production, Factory Manager, QC (Chemical, Food, Textile, Other Materials)

Company Details

Company Type International Company