Medical Quality Engineer - (US-OH-Mentor - 44061)

Minimum Education: None
Job Type: Full Time
Jobcode: N/A
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Responsibilities: Responsible for implementing/maintaining product quality documents (i.e. inspection procedures, statistical techniques, sampling plans, Device Master Records (DMR), Device History Records (DHR) and certificates of analysis/conformance etc€¦) Lead Problem resolution efforts (FMEA, K-T, DOE's, etc.) Lead problem resolution and follow up for corrective and preventative action inclusive of identified continuous improvement activities. Assist RA/QA team with the ongoing and continuous training of quality procedures, techniques and concepts in accordance with the FDA Quality System Regulations/ISO 13485 Participate as a member of the internal audit team as a lead auditor and train internal auditors (includes scheduling audits, conducting audits, writing reports and issuing corrective and preventive actions where necessary) Conduct daily floor audits of the production area including Medical Finishing and Cleanroom production Assist new product development with all IQ,OQ,PQ activity with new product development. Facilitate Customer Audits Provide direct customer assistance regarding quality issues. .

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