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Date:  May 5, 2026
Location: 

Seoul, KR

Job Type:  Long-term / Regular

 Quality Assurance Specialist M/F (30603)

 

At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.

 

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.

 

Achieve, Cooperate, Care and Innovate are the values ​​that we share and practice on a daily basis.

 

Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.

 

For more information on Guerbet, go to www.guerbet.com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube

 

Main responsibilities

  • Register as a qualified person for medical device importation
  • Act as site Quality lead for regulatory agencies and corporate interfaces
  • Ensure Quality Management System for Guerbet Korea & Imaging Solution Korea
  • Develop and maintain the local quality assurance system and SOPs in line with the HQ quality management system
  • Ensure all cGMP requirements are fulfilled for released of finished goods (drug products and medical devices) in accordance with MFDS requirements
  • Manage the process that develops, establishes, and maintains quality assurance programs, policies, process, procedures and controls ensuring that performance and quality of finished products (drug products and medical devices) in accordance with MFDS requirements
  • Identify, develop and execute quality plans and project timelines to meet group, site and company goals
  • Fulfill quality activities(Change control, deviation, product complaint, audit, training, documentation, recall, etc.) by cGMP requirements and Korean regulations.
  • Report to Corporate and support domestic customer response in case of product complaints and prepare for the complaint trend report
  • Prepare for regular inspection by the MFDS
  • Establish, fulfill and evaluate annual training plan
  • Receive Annual Product Quality Review from the production site and draft local report
  • Manage finished product release(using SAP system) & and third-party labs including method transfer
  • Manage the Korean package artworks and Korean drug barcode in compliant with local standards
  • Oversee incoming inspection of the finished products for physical appearance and label codes
  • Oversee re-labeling activities – Prepare Korean-specific labeling by MFDS requirement
  • Manage local warehouse with Supply Chain team according to the local requirement
  • Provide quality input as a GMP compliance matter expert
  • Manage the reference/retention samples process
  • Will interact with Corporate or APAC support groups to drive quality programs.

Education, background required for the job

  • Relevant qualification in bachelor’s degree(pharmacy, bio, or chemistry-related background preferred)
  • Around 10 years of experience in QA in the pharmaceutical and/or medical device industry
  • Proficient in MS Office
  • Effective communication and interpersonal skills
  • Good verbal and writing English skills
  • Work systemically according to regulations

 

Reason to join US

Much more than a Competitive salary,


We offer continued personal development. When you join Guerbet, you :

  • Are choosing a global leader with recognized expertise in diagnostic and interventional imaging, 
  • Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient’s life all over the world,
  • Are joining a company where we value diversity of talents coming from various horizon.

 

We # Innovate # Cooperate # Care #Achieve at Guerbet. 

 

Guerbet is an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. Guerbet is committed to diversity, equity, and inclusion.

 

Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position please send an email to careers@guerbet.com or you can also call this number +19843443717

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