Quality Assurance Manager, Japan

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Position Overview

We wish to recruit an experienced, hands-on Quality Assurance Manager with a deep understanding of how quality principles are best applied within the IVD or medical devices industry. The successful applicant will be able to demonstrate a rounded knowledge of quality assurance and its relationship with regulatory requirements, as well as having prior experience of hosting regulatory audits.

A self-motivated individual is required as this role will lead and oversee the system that ensures conformance of Exact Sciences’ Japanese operations with internal and external quality systems requirements. A ‘One Exact’ mindset will be necessary and therefore the role will involve close collaboration across department and geographical divisions within the company.

The place of work is Exact Sciences K.K., EGG Japan (9th Floor), Shin Marunouchi Building, 1-5-1 Marunouchi Chiyoda-ku, Tokyo, 100-6509 Japan.

Essential Duties

Include, but are not limited to, the following :

• Lead the implementation of QMS processes and ensure these integrate with Exact Sciences’ QMS harmonization plans.
• Host audits by external regulatory bodies in Japan such as MHLW, PMDA or Tokyo Metropolitan Authority necessary to maintain licenses and product approvals
• Fulfill the requirements of Japanese regulatory roles relating to quality assurance e.g. Domestic Quality Assurance Manager and General Marketing Compliance Officer.
• Communicate status and professional opinions relating to the quality management system with company top management.
• Support QMS changes necessary for new product introduction into the Japanese market in line with ISO 13485, Ordinance 169 and Japanese regulatory requirements.
• Approval and oversight of releases and changes to Exact Sciences’ medical device / IVD products available within the Japanese market
• Develop new and existing QMS processes as required to meet business needs.
• Support QMS processes relevant to Exact Sciences’ clinical laboratories in line with CAP / CLIA and ISO15189.
• Lead audits of suppliers based in Japan or within the broader Asia-Pacific region as required.
• Lead quality agreement development with critical suppliers important to operations in Japan.
• Lead or support Exact Sciences’ internal audit program as required.
• Lead improvement processes relating to Japanese operations i.e. non-conforming event management, root cause analysis, corrective / preventive action and effectiveness checks.
• Lead activity relating to any field safety corrective actions / recalls relating to Japan.
• Work as part of project teams to ensure QMS and applicable regulatory compliance.
• Support the day-to-day administrative requirements of the quality management system as required, including document control and record keeping.
• Assist in the design of training programs for QMS procedure implementation.
• Train relevant employees in QMS procedures owned by QA.
• Revise processes in line with audit findings.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Support and comply with the company’s Quality Management System policies and procedures.

Skills

Physical and Travel Requirements

Minimum Qualifications

Preferred Qualifications

LI-BP1

Employment Term : This role includes a 3-month probationary period during which employment conditions remain unchanged. Employment is on an indefinite-term contract, and a one-month notice period is required for voluntary resignation, in accordance with company policy. Employees may be required to work overtime based on business needs, including occasional holiday and weekend work, with compensation provided per company policy and local labor regulation.

Salary Range :

8,166,000 - ￥12,250,000

The annual base salary shown is a national range for this position on a full-time basis and may differ by hiring location. Additionally, this role includes either 30 hours of overtime per month or 10 hours of midnight work per month, depending on the position. This position is also eligible for a bonus.

Employee Benefits : Exact Sciences is committed to providing a comprehensive employee experience that supports well-being and professional growth through our benefits. Learn more about our benefits by selecting the country you're interested in to view specific offerings. Based on business needs and role eligibility, relocation support may also be available in accordance with company policy.

Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, please contact us here .

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