Quality Assurance Specialist

JOB SUMMARYThe Quality Process Analyst solves quality problems and is involved in quality improvement projects. This role can perform the document control processes, which includes making document changes, routing for review and approval, making documents effective, distribute documents and make notifications. In addition, the Quality Process Analyst can execute the training process, which includes routing training assignments, ensure training has been completed and filing training records. Also, the role will help level-load work by supporting and backing up Inspectors and Quality Engineers.ESSENTIAL JOB DUTIES & RESPONSIBILITIESFollow all procedures and work instructions defined in the Quality System ManualExecute Document Change RequestsCoordinate trainingAssist in executing calibration activitiesAssist in RMA processPerform InspectionsSupport all audit activitiesPerform other duties as assigned by manager or supervisorEDUCATION & EXPERIENCE REQUIREMENTMust have proven attention to details and excellent organization skillsMinimum of two-year degree or equivalent experience; ability to apply learned technology to Company products and processesIntermediate proficiency with Microsoft Word & Excel, Adobe Acrobat, LabelView, eQMS, SysproMust possess excellent verbal and written communication skills in English, which includes the ability to read, write and speak to comprehend and execute internal procedures, drawings and Manufacturing Work Instructions (MWI's)PREFERRED SKILLS & ABILITIESMedical device industry experienceMedical Device regulation requirements knowledge, as applicable to responsibilitiesASQ certification as a Quality Process AnalystWORKING CONDITIONS & PHYSICAL DEMANDSRegularly sit at a computer workstationMust be able to fulfill all requirements for cleanroom accessAbility to lift and move materials and product up to 55 lbs.

Created: 2025-10-02