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QA Senior Manager - Yongin-si, 대한민국. - Abbott
설명
MAIN RESPONSIBILITIES
ᆞEnsure a Quality system is in place in compliance with Regulatory and ISO standards
ᆞLead QA organization (HC 20~30) to implement compliance, supplier quality, design quality, change control and internal audit, Post market surveillance
ᆞExpertise in ISO, GMP international standards
ᆞMake release decisions of finished products
ᆞLead Quality Management Remediation Project to meet Abbott quality standards
QUALIFICATIONS
ᆞOver bachelor degree in relevant major (Knowledge on diagnosis mechanism (Biological, Immunization)
ᆞLeadership experience in quality systems (> 10 years) in Pharmaceutical , medical device or IVD
ᆞExperience in leadership role in organization more than 10 HC
ᆞExperience in IVD with understaing of ISO , EU 2017/746(IVDR) and other rapid diagnostic device related international requirement
ᆞExcellent communication skill in English (in technical writing and conversation)
ᆞExceptional communication skills and ability to facilitate cross-functional cooperation
ᆞPreferred employment in global, international IVD, pharmaceutical firms(> 5 years)
Experience/Background
Experience Experience Details
Minimum 15 years