What are the responsibilities and job description for the QA Senior Manager position at Abbott?
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 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 years
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 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 years
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