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Senior Quality Assurance Engineer - Los Angeles, United States - BioTalent
Description
About the jobGeneral Description
This position must has significant experience and also display strong leadership capabilities. This position is a QMS subject matter expert.
Job Knowledge And Duties
Open, investigate, and close NCRs
Open, investigate, and close complaints
Create metric reports as assigned
SPC Monitoring
Participate in CAPA Projects
Participate in validation & measurement capability projects
Update procedures as required
Identify and perform continuous improvement projects
Product line ownership
Execute validations
Create control plans and PFMEAs
Perform Internal Audit
Perform Supplier Qualification and audits
Customer facing role, run Drumbeat customer meetings
Leadership role, direct reports of Inspectors or Technician
Owner of critical Quality Subsystems
Act as SME in regulatory inspections
Education, Experience, Skills, And Knowledge
4 Year Degree or equivalent experience
Minimum years' experience
Proficient with math, statistics, and reading comprehension
Proficient with computer skills (Microsoft Office, etc.)
Basic understanding of QMS
Working knowledge of Excel and database programs
Solid understanding of Quality System Regulations (complaint, NCR, containment, root cause, etc.)
Functional Quality statistical knowledge (AQL, sampling, etc.)
Proficient with QMS
Strong leadership abilities
Capable of independent project management
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