Quality Control Manager

My client is a global biotechnology company currently seeking a Quality Control Manager to join their team. This role will be instrumental in ensuring the highest standards of quality are maintained across all QC operations, particularly in support of their innovative therapeutic pipeline. You will also oversee quality control operations related to medical devices at the company's manufacturing facility located in Chiba Prefecture, Japan.

Responsibilities:

• Lead quality control operations for medical devices at a manufacturing facility in Chiba Prefecture, including inspection, storage, packaging, and labeling processes.
• Perform inspections and investigations using mechanical and optical measurement tools, including high-powered laser devices.
• Ensure accurate and compliant documentation of quality control activities across both paper-based and electronic systems.
• Support risk management activities and evaluate changes from internal teams and external manufacturing partners, in alignment with ISO 14971 standards.
• Collaborate with global cross-functional teams on complaint handling, nonconformance investigations, CAPA, change control, and supplier assessments.

Requirements:

• Bachelor's degree in engineering, science or related field
• At least 2 years of experience in medical device industry
• Quality control experience including storage, labelling and packaging of medical devices, CAPA, QMS etc
• Thorough knowledge is expected of ISO 13485 and MHLW MO 169

If you are interested, please apply with your CV attached.