Sr Quality Assurance Analyst　品質保証

求人詳細

Lead and grow a vital Quality Management System (QMS) for a dynamic, innovative medical device company in Japan.

About the company
Our client is a pioneering global leader in the medical technology industry, committed to improving patient lives through cutting-edge solutions. They foster a collaborative and supportive environment, valuing innovation and continuous improvement. They offer excellent benefits and growth opportunities within a rapidly expanding organization.

Role & Responsibilities
You will be a key player in establishing, maintaining, and improving the company's Quality Management System (QMS) in Japan, ensuring compliance with all relevant regulations. You will lead critical quality operations, collaborating closely with cross-functional teams and external stakeholders. This is a high-impact role where you'll directly contribute to ensuring the safety and efficacy of life-changing medical devices.

Main tasks include
・Lead the implementation and maintenance of the QMS, ensuring compliance with Japanese regulations.
・Manage document control, training programs, and change management processes.
・Conduct internal and external audits, and drive continuous improvement initiatives.
・Support manufacturing activities, including quality checks and product release decisions.
・Collaborate with regulatory affairs and safety teams on product lifecycle management.
・Manage supplier relationships and ensure compliance with quality standards.

If you are interested in this exciting opportunity, apply now.
We look forward to hearing from you.
#LI-Hybrid
#LI-KN

こんな方を求めています

経験・スキル

Requirements
・Minimum 5 years of experience in quality assurance within the medical device or IVD industry.
・Proven experience in QMS establishment, maintenance, and improvement.
・Experience leading internal and external audits.
・Experience in product realization processes, including risk management.
・Strong understanding of Japanese medical device regulations (J-PMD Act, etc.).
・Excellent communication skills in Japanese and English.
・Strong leadership, problem-solving, and analytical skills.
・Experience with CAPA (Corrective and Preventive Actions).
・Experience with documentation and record-keeping systems.
・Bachelor's degree in a related scientific or engineering field.

学歴

大学卒業以上

募集要項

職種

品質保証、品質管理

給与

年収 700 〜 1,100万円

賞与

11%

雇用形態

正社員

雇用期間

期間の定めなし

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

受動喫煙防止措置

敷地内禁煙

業種

医療機器・医療品関連

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