品質保証専門職/ Quality Assurance Professional

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.

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+)

About the Company:

Specialising in advanced medical products and services, the company pioneers innovative solutions in wound care, continence care, and critical care. With a commitment to enhancing the quality of life for patients worldwide, it continually drives forward with cutting-edge technologies and compassionate care.

Keywords:

製薬, メディカル, サイエンス, 求人, 外資系

Job Ref: M86DT9