Quality Assurance Manager, Japan (QA Manager)

Overview:

A very exciting and growing diagnostics healthcare company is seeking an experienced Quality Assurance (QA) Manager to lead and oversee Japan’s quality management system (QMS). The role ensures compliance with internal and external regulatory requirements and involves collaboration with global QA and cross-functional teams.

Key Responsibilities:

• Lead implementation, maintenance, and improvement of ISO 13485 / Ordinance 169–based QMS.

• Host and manage audits by regulatory authorities (e.g., MHLW, PMDA).

• Serve as Domestic Quality Assurance Manager and General Marketing Compliance Officer under Japanese regulations.

• Oversee product release, change control, and new product introduction processes.

• Conduct supplier audits, manage quality agreements, and drive CAPA and continuous improvement.

• Support clinical laboratory QMS compliance (CAP/CLIA, ISO15189).

• Provide QA training and ensure compliance with internal and external standards.

Skills & Competencies:

• Strong understanding of QMS and regulatory frameworks (ISO 13485, Ordinance 169, PMD Act, GVP).

• Skilled in auditing, document control, risk management, and process improvement.

• Excellent communication and presentation skills in Japanese and English.

• Detail-oriented, self-motivated, and collaborative mindset.

Qualifications:

• Bachelor’s degree in a scientific discipline (Master’s preferred).

• Certified Quality Systems Auditor.

• 5+ years in QA within the IVD/medical device industry.

• Experience with regulatory audits and cross-functional QA leadership.

• Eligibility to work in Japan without sponsorship.