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About this Candidate
DAVRON Report for this Quality Engineer:
- Holds a B.S. in Mechanical Engineering with experience supporting ISO 9001 and ISO 13485 quality systems in medical device and manufacturing environments
- Skilled in implementing quality processes including quarterly dose audits, sterility testing, risk analysis, and inspection protocols for cleanroom operations
- Experienced in launching new product lines and drafting SOPs, IQ/OQ/PQ documentation, and regulatory submissions; managed product data libraries and quality documentation systems
- Proficient in ERP systems such as Infor Syteline and CAD software including Creo, SolidWorks, and AutoCAD
- Led root cause investigations and 8D analyses for corrective actions; supported internal and customer audits and trained teams on good documentation practices and quality procedures
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