Quality Assurance Specialist
Posted on :
15-06-2022
Employer Active
1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
15-06-2022
Job Description
Req ID : 1145986
Quality Assurance Specialist with experience in regulated industry to ensure compliance based on applicable regulations (e.g., FDA), policies and procedures. Align local Policies and Procedures with ADC Division and assure full compliance with local regulations.Work with the different Affiliate departments, such as Commercial, ADC Division, and other divisions on the development and maintenance of the Quality Management System (QMS), including: Quality Manual, Org Chart, Job Descriptions, Policies and Procedures, Document Management, Training Management, Training Plans, Training Compliance, Supplier Management File (SMF), Authorization for Shipment (AFS) and CAPA - Corrective Action / Preventive Action.
Responsibilities:
- Follow applicable Quality Standards.
- Proven data collection, management and analysis.
- Problem analysis and problem solving.
- Customer service driven.
Requirements
Bachelor degree in Engineering or Science with minimum of 3 yearsof relevant experience in a regulated environment
ISO 13485 certificate
FDA 21 CFR 820 certificate
Lean Six Sigma Green Belt certification
Bilingual (English/Spanish)(Verbal and Written)
Microsoft Office
Bachelor degree in Engineering or Science with minimum of 3 years of relevant experience in a regulated environment ISO 13485 certificate FDA 21 CFR 820 certificate Lean Six Sigma Green Belt certification Bilingual (English/Spanish)(Verbal and Written) Microsoft Office
Employment Type
Full Time
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