The Sr. Quality Engineer oversees the validation process, the QMS system and participates in the Internal Quality Audits.
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.
Capability Analysis (CpK, Normality, T-Test,) utilizing Minitab.
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.