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Job ID : 1151532 Date Updated : January 20th, 2022
Rapidly expanding Global Biotech Company

Quality Assurance, Medical Device

Hiring Company Global Biotech Company
Location Tokyo - 23 Wards
Job Type Permanent Full-time
Salary 7 million yen ~ 12 million yen

Job Description

Position overview:
This position will directly report to Quality Assurance supervisor Japan and have responsibility for leading the execution of all Quality Assurance activities for mainly Medical Device.
Key Duties and Responsibilities:


• Support Quality Assurance supervisor to achieve Japan Commercial Operations objectives from Medical device perspective
• When Quality Assurance issue arises, lead to define the appropriate Quality measurement through the communication with the related internal, global and external parties.
• Ensure full compliance with applicable regulations in Japan.
• Oversee all activities or responsibilities that are delegated to external parties.

General Requirements

Minimum Experience Level Over 3 years
Career Level Mid Career
Minimum English Level Business Level
Minimum Japanese Level Native
Minimum Education Level Bachelor's Degree
Visa Status Permission to work in Japan required

Required Skills

• 4+ years of Quality Assurance experience in Medical Device industry.
• Experience of managing Medical Device class Ⅱ or Ⅲ
• Experience of complaint handling
• Experience in both clinical and post-marketing environment.
• Understanding of PMD Act, relevant regulations and guidelines.
• Thorough knowledge of drug and medical device development process.
• Very good communication and problem solution skill among cross-functional team.
• Bachelor's Degree in Science or related discipline
• Knowledge of relevant in Quality Assurance in pharma industry is plus.

Job Location

  • Tokyo - 23 Wards

Work Conditions

Job Type Permanent Full-time
Salary 7 million yen ~ 12 million yen

Hiring Company Information

Company Type Small/Medium Company (300 employees or less) - International Company
Recruiter Company Information

Cornerstone Recruitment Japan K.K.

Quality Assurance, Medical Device Job Information | Work in Japan · Jobs with International Companies · Jobs that Use English · CareerCross

Company Description

Cornerstone Recruitment Japan is focused on placing bilingual professionals in a wide range of market leading companies.

Focusing across all sectors, we leverages the network of our experienced consultants to provide both clients and candidates with high end service levels and most importantly results.
We are passionate about helping our clients in securing the best talent on the market, by introducing unique profiles who can give them the edge in an increasingly competitive recruitment market.
Established in 2019, in partnership with Cornerstone Global Partners and with investment from Morgan Stanley, Cornerstone Recruitment Japan strives to be the recruitment partner of choice for all Tokyo based clients and candidates.

Our Mission

The Cornerstone. As every building requires a cornerstone, we believe people are the cornerstone of every great company.
​Our recruitment experts are passionate about bringing together great people with great companies.

Our Business Sectors

  • Accounting & Finance
  • Financial Services
  • Human Resources and Office Professionals
  • Industrial
  • Information Technology
  • Legal & compliance
  • Life Science
  • Supply Chain & Procurement
  • Marketing
  • Sales

Our Services

  • Contingency

Many clients choose to utilize our success based contingent recruitment service. We take the time to fully understand the job brief before presenting a tailored shortlist of 5 to 6 candidates from our expansive existing network. This service comes with no obligation to hire and our clients only pay a fee when the successful candidate joins.

  • Retained

Our retained service is particularly successful for clients with high profile/critical hiring needs, or niche searches that involve a significant amount of time unearthing candidates from outside our existing network. Clients who choose our retained service benefit from the introduction of exclusive headhunted candidates and top prioritization from the Cornerstone team.

  • Market Entry

With a wealth of experience in the Japan market, our consultants have successfully helped many clients enter the Japan market. We can help you secure that critical first hire, as well as providing a consultation service, to make sure that your business is well prepared for all the initial hurdles it will face.

Cornerstone Recruitment Japan is focused on placing bilingual professionals in a wide range of market leading companies.

Focusing across all sectors, we leverages the network of our experienced consultants to provide both clients and candidates with high end service levels and most importantly results.
We are passionate about helping our clients in securing the best talent on the market, by introducing unique profiles who can give them the edge in an increasingly competitive recruitment market.
Established in 2019, in partnership with Cornerstone Global Partners and with investment from Morgan Stanley, Cornerstone Recruitment Japan strives to be the recruitment partner of choice for all Tokyo based clients and candidates.

Our Mission

The Cornerstone. As every building requires a cornerstone, we believe people are the cornerstone of every great company.
​Our recruitment experts are passionate about bringing together great people with great companies.

Our Business Sectors

  • Accounting & Finance
  • Financial Services
  • Human Resources and Office Professionals
  • Industrial
  • Information Technology
  • Legal & compliance
  • Life Science
  • Supply Chain & Procurement
  • Marketing
  • Sales

Our Services

  • Contingency

Many clients choose to utilize our success based contingent recruitment service. We take the time to fully understand the job brief before presenting a tailored shortlist of 5 to 6 candidates from our expansive existing network. This service comes with no obligation to hire and our clients only pay a fee when the successful candidate joins.

  • Retained

Our retained service is particularly successful for clients with high profile/critical hiring needs, or niche searches that involve a significant amount of time unearthing candidates from outside our existing network. Clients who choose our retained service benefit from the introduction of exclusive headhunted candidates and top prioritization from the Cornerstone team.

  • Market Entry

With a wealth of experience in the Japan market, our consultants have successfully helped many clients enter the Japan market. We can help you secure that critical first hire, as well as providing a consultation service, to make sure that your business is well prepared for all the initial hurdles it will face.