[의료기기/품질관리] Senior QA Specialist

A Senior QA Specialist position is now open at an international medical device company. The qualified applicant will be driving the adherence of QMS with relevant regulatory specifications. This role is based in Seoul.

Responsibilities:

• Evaluate QMS specifications to enhance the structure
• Determine enhancements and inputs into the quality planning procedures
• Participate in the creation, maintenance, and enhancements of QMS
• Establish and facilitate QMS training
• Coordinate with key functions and health organisations
• Engage in cross-functional QA programs

Requirements:

• Bachelor’s degree or above in science or a relevant field
• More than 3 years of quality assurance or regulatory affairs experience in the medical device or pharmaceutical business
• Understanding of quality systems (CAPA, audits, management review, etc.)
• Familiarity with local medical device regulations
• Ability and willingness to travel
• Business level English

About the Company:

Headquartered in the US, this medical device organisation has seen great success throughout its history. Their products are sold in a number of countries across the globe and have been ranked as one of the world’s best places to work for.

1831290/001