Technical Quality Assurance

2 weeks ago


Zelienople, United States JobRialto Full time

Job Description:This position is responsible for conducting routine inspection and analysis of incoming service material and quality reviews of domestic and international service records by identifying conflicts, dependencies, and risk of release to ensure Quality Assurance Standards and procedures are met.QualificationsExcellent communication and team skills as well as a keen attention to detailAssociate Degree in a related technical field or equivalent experienceWorking knowledge of Microsoft Office Suite, Excel, Word, etc.Operate to the requirements of FDA 21 CFR Part 820 and ISO 13485Basic understanding of Good Manufacturing Practices (GMP) and Quality System Regulations (QSR)Familiar with a variety of measurement equipmentResponsibilitiesEnsure compliance of purchased parts delivered to ServiceUtilize basic measurement tools to inspect parts (Micrometers, calipers, height gage, thread gage, scales, pin gages, etc.)Perform inspections, checks, and follow sampling procedures according to the applicable instructions on products having been delivered by suppliers before their use in productionProcess all appropriate paperwork for inspection operationsAccept or Reject products as defined in the inspection instruction/ checklistAccurately document non-conformity when applicable with clear characterizationMaterial Review Support - May be asked to support investigation of electrical/electronic or mechanical parts to determine root causes of failures and to assist with dispositions of failed partsProcess service records for Client Direct and Contract Service Providers (CSP) by reviewing paperwork for accuracy, completeness, and correctnessPerform Device History Reviews (DHR) and Process Failure Mode and Effects Analysis (PFMEA) reviews in support of complaint investigationsPerform other duties as assignedAdditional client information:



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