Assess potential suppliers for technical, quality, and manufacturing capabilitiesAnalyze incoming material defects and communicate issues to suppliersInvestigate field failures related to supplier materialsLead project teams to drive improvement for supplier quality issuesDevelop and disposition corrective action plans for non-conforming materialGenerate and maintain incoming inspection proceduresProvide input from component quality, reliability, and manufacturing perspectives

Investigate complaints/events in a timely mannerPrepare technical reports of analysis/findingsMaintain accurate entry of complaints in EPIQCoordinate product testing/analysis with other departments and external consultantsWork collaboratively with cross-functional groups on evaluation trends or findingsInterpret technical product specifications, Device History Records, or measurementsUtilize safe bio-hazard and chemical handling practices

Update risk management documentation to align with EU MDRCoordinate with remediation team members across multiple departmentsEnsure corrective measures meet reliability standardsConduct risk analysis of post-market productsRecommend methods to achieve mandated levels of product reliability

Develop device testing methods under physiological parameters for data analysisCollaborate with sponsors and study directors to ensure study objectives are metSupport awake and anesthetized monitors with equipment set-up and data collectionEnsure equipment is properly installed and calibrated per ISO 17025