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- 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
- 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
Senior Quality Assurance Engineer - California, United States - BioTalent
Description
About the job
General 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
Education, Experience, Skills, And Knowledge