募集要項
- 募集背景
- A global medical devices company is looking for a Quality Assurance Professional. The selected candidate will oversee and improve quality and safety systems for medical devices.
- 仕事内容
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A global medical devices company is looking for a Quality Assurance Professional.Responsibilities:
* Establish and enhance QMS and safety systems for medical devices
* Lead internal audits and ensure regulatory compliance
* Manage supplier QMS including supplier audits
* Coordinate with regulators on recalls and external audits
* Respond to customer complaints and product inquiries
* Collaborate on investigations and quality improvements with manufacturers
Requirements:
* Bachelor's degree or above in science (engineering is ideal)
* 8-12 years of professional experience
* More than 6 years of experience in quality assurance (medical device or healthcare product industry)
* Knowledge of ISO 14971, ISO 13485
* Familiarity with compliant handling, product development lifecycles, risk management in a medical device setting
* Understanding of QMS Ministerial Ordinance
* Proficient in written and spoken English (TOEIC 500+)
- 応募資格
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- 必須
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8-12 years of professional experience
- 歓迎
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More than 6 years of experience in quality assurance (medical device or healthcare product industry)
- 雇用形態
- Permanent
- 勤務地
- Tokyo
- 年収・給与
- JPY12,000,000.00 - JPY14,000,000.00 per annum
- 休日休暇
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weekends off, public holidays, paid holidays
