Job opening - Sr Quality Assurance Specialist at Global Medical Device Leader in 東京23区 | Randstad

summary

東京23区, 東京都
¥9,000,000 - ¥11,000,000 per year, 年収900 ～ 1,100万円
permanent

job category
biotechnology & pharmaceutical

job details

社名
社名非公開

職種
安全性管理、品質保証、品質管理

業務内容 ...

Lead and grow a dynamic QMS in Japan – a rewarding opportunity in the medical device industry.About the companyOur client is a global leader in continuous glucose monitoring (CGM), pioneering innovative technologies and improving lives worldwide. They foster a collaborative and driven culture.RoleRole & ResponsibilitiesYou will be the driving force behind establishing, maintaining, and improving a QMS, based on Japanese regulations. You will lead key quality operations, ensuring the highest standards of quality and compliance are met.Main tasks include•Lead document/record control and training processes.•Manage change management of regulatory requirements.•Lead internal/external audit processes.•Lead process monitoring/measurement, data analysis, process improvement, and CAPA.•Support manufacturing activities from a quality/regulatory perspective.

求められる経験
Requirements
•Minimum 5 years of experience in Quality and QMS/QC activities in the medical device/IVD industry.
•Experience in QMS establishment, maintenance, and activities.
•Experience leading internal/external audits.
•Experience leading Product Realization activities.
•Native-level Japanese and business-level English communication skills.

保険
健康保険　厚生年金保険　雇用保険

休日休暇
土曜日　日曜日　祝日

給与
年収900 ～ 1,100万円

賞与
ー
雇用期間
期間の定めなし

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社名
社名非公開

職種
安全性管理、品質保証、品質管理

業務内容
Lead and grow a dynamic QMS in Japan – a rewarding opportunity in the medical device industry.About the companyOur client is a global leader in continuous glucose monitoring (CGM), pioneering innovative technologies and improving lives worldwide. They foster a collaborative and driven culture.RoleRole & ResponsibilitiesYou will be the driving force behind establishing, maintaining, and improving a QMS, based on Japanese regulations. You will lead key quality operations, ensuring the highest standards of quality and compliance are met.Main tasks include•Lead document/record control and training processes.•Manage change management of regulatory requirements.•Lead internal/external audit processes.•Lead process monitoring/measurement, data analysis, process improvement, and CAPA.•Support manufacturing activities from a quality/regulatory perspective.

求められる経験
Requirements
•Minimum 5 years of experience in Quality and QMS/QC activities in the medical device/IVD industry.
•Experience in QMS establishment, maintenance, and activities.
•Experience leading internal/external audits.
•Experience leading Product Realization activities. ...

show more

experience
Requirements • Minimum 5 years of experience in Quality and QMS/QC activities in the medical device/

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