Associate, Quality Assurance (QMS)

About the role

IQVIA is looking for an Associate, Quality Assurance in Shinjuku to support the QA senior manager in maintaining a proper quality management system (QMS) for a client (MAH). The role covers QMS documentation, complaint handling, change control, recalls and audits, with remote work possible 3-4 days per week. Fluent Japanese is required.

Key responsibilities

• Support the QA senior manager with QMS operations and maintenance, including QMS, FMR and MAH licence applications
• Manage quality, manufacturing and distribution control, including non-conforming goods and final release
• Translate English complaint investigation reports into Japanese and prepare customer letters, including correspondence with overseas manufacturers
• Create, update and archive QMS documents such as SOPs, records, J-DMR and quality agreements, and handle e-mail and telephone correspondence in Japanese and English
• Handle change control, corrective and preventive actions, purchase control and training of staff
• Manage recalls and ad-hoc applications for MAH and distributor licences
• Prepare QMS inspection and FMR applications and explain them to clients, and respond to audits by the PMDA, notified bodies and customers

Required profile

• Bachelor's degree or graduation from a technical college
• At least 2 years of experience in quality, manufacturing or regulatory fields (medical devices or electrical products)
• Business-level spoken English (TOEIC 700+) and ability to read, write and communicate by e-mail
• Able to translate simple sentences between Japanese and English without a dictionary or tool

Required skills

• General PC skills: Word, Excel, PowerPoint
• Knowledge of QMS, FMR, MAH licence, PMDA regulations and GVP

Occasional travel is required, including visits to overseas manufacturers for training. The position is open to candidates with a strong team spirit and good relationships with colleagues, subordinates and managers, and offers the chance to take on QMS consulting work depending on fit.