QA Manager/Senior Manager
Our client, a leading global biotechnology company, is seeking a highly motivated QA Manager/Senior Manager to join their team in Tokyo. This role is critical in ensuring the quality and compliance of medical device operations in alignment with international and local regulatory standards.
Key Responsibilities
- Develop and maintain comprehensive documentation for processes supporting the medical device quality management system.
- Evaluate and manage supplier performance both domestically and internationally, collaborating to resolve quality issues and ensure compliance.
- Lead or support internal and external audits, including planning, execution, and closure, while providing subject matter expertise.
- Partner with global teams to manage complaint handling, nonconformance, CAPA, change control, and supplier assessments.
- Regulatory Compliance: Monitor and ensure adherence to current regulations and standards, including ISO 13485, MHLW MO 169, and the Japanese FMD Act.
- Continuous Improvement: Drive quality system improvements by identifying gaps, implementing corrective actions, and enhancing overall process effectiveness.
Qualifications
- Bachelor's degree in Engineering, Science, or a related field.
- Minimum of 4 years' experience in a regulated industry; medical device experience preferred.
- Proven expertise in quality assurance activities such as QMS, CAPA, and audits.
- Strong knowledge of the Japanese FMD Act, ISO 13485, and MHLW MO 169.
- Bilingual proficiency (Japanese and English) with excellent communication skills.
If you are interested, please apply with your CV attached.
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your CV and details on file so when we see similar roles or see skillsets that drive growth in organisations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.
That's why we recommend registering your CV so you can be considered for roles that have yet to be created.
Yes, we help with CV and interview preparation. From customised support on how to optimise your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.