QA Specialist

求人詳細

Position: Quality Assurance Specialist

About the Role
We are seeking a dedicated Quality Assurance (QA) Specialist to join our dynamic team in Yokohama. Reporting to the Senior Manager of RA/QA Japan, this critical position will play a key role in maintaining and improving our quality management systems.

Responsibilities
The QA Specialist will be responsible for:
● Implementing and maintaining quality systems in compliance with ISO-13485, PMD_169, and other relevant guidelines, acting as a Quality Specialist (Sekinin-Gijutsusya / Kokunai-Hinseki)
● Developing and enforcing quality systems to ensure product and service quality meet customer satisfaction requirements
● Managing comprehensive quality management system (QMS) planning, implementation, and maintenance
● Establishing and maintaining effective communication processes related to QMS effectiveness and customer interactions
● Standardizing and aligning Japan Quality Assurance practices with global corporate headquarters processes
● Overseeing critical quality management areas, including:
- Document control
- External provider control
- Record management
- Calibration
- Corrective and preventative actions (CAPAs)
- Change control
- Customer complaint and feedback management
- Internal auditing
- Training and proficiency
- Equipment and standard material control
- Data review and reporting
- Disaster recovery and safety protocols
● Ensuring compliance with applicable licenses, agreements, and certificates
● Coordinating with cross-functional teams to maintain regulatory compliance in Japan

こんな方を求めています

経験・スキル

Educational Requirements
● Bachelor's degree minimum in Engineering or Life Sciences such as
Medical testing, Laboratory medicine, Medical engineering, Chemistry, Biology, Pharmaceutical sciences

Professional Experience
● 3-5 years of QA experience in a medical device company
● Proven track record in:
- Transforming quality processes
- Improving systems and organizational culture
- Developing and implementing change initiatives

Required Skills
● Exceptional attention to detail
● Strong ability to work independently
● High level of commitment and follow-through

Language Requirements
● Japanese/Business Level English

学歴

大学卒業以上

募集要項

職種

安全性管理、品質保証、品質管理

給与

年収 550 〜 950万円

賞与

10%

雇用形態

正社員

雇用期間

期間の定めなし

試用期間

有り

就業時間

09:00～18:00

休日休暇

土曜日　日曜日　祝日

保険

健康保険　厚生年金保険　雇用保険,健康保険,厚生年金保険,介護保険

受動喫煙防止措置

敷地内禁煙

特長

上場企業, 外資系企業, 月平均残業時間20時間以内, 完全週休2日制, 土日祝休み, 語学力を活かす

業種

医療機器・医療品関連

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