Quality Engineer in Butler,WI,US
Job
W3global
Butler, WI (In Person)
Full-Time
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Job Description
Position Description SUMMARY:
- The Quality Engineer oversees the validation process, the QMS system and participates in the Internal Quality Audits.
- Position reports to the QA Manager
JOB DUTIES
- Perform operation and programming of OGP Smartscope.
- Write and maintain FDA level validation protocols and reports.
- Support quality planning activities on new and existing programs.
- Investigate customer quality issues and requests.
- Interpret and implement ISO9000/13485 and FDA standards.
- Assist in preforming internal audits.
- Maintain Calibration System.
- Perform other duties as assigned. Position Requirements
- Requires education that is generally found in Bachelors degree in engineering or equivalent combination of education and experience.
- Requires three to five years of previous experience in quality engineering to become familiar with the use of testing devices, techniques, and test procedures.
- Requires two years medical device industry experience.
- Proficiency in MS Word, Excel, Access, and Minitab.
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