QA Senior Manager
Abbott
- 경기도 용인시
- 정규직
- 풀타임
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 standardsQUALIFICATIONSㆍOver 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 13485-2016, 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 yearsThe base pay for this position is N/AIn specific locations, the pay range may vary from the range posted.JOB FAMILY: Operations QualityDIVISION: IDEM ARDx Infectious Disease Emerging MarketsLOCATION: Korea
Yongin-si : 65 Borahagal-roADDITIONAL LOCATIONS:WORK SHIFT: StandardTRAVEL: Yes, 10 % of the TimeMEDICAL SURVEILLANCE: Not ApplicableSIGNIFICANT WORK ACTIVITIES: Not Applicable