Quality Engineer II - Medical Devices, Post-Market

Established publicly-held medical device catheter manufacturer is looking for a Quality Engineer II to add to their Post-Market Quality Engineering/Complaints Analysis team.ResponsibilitiesPerform Returned Goods and failure analysis on returned productsPerform Complaints Investigations & Ensure complaints are prioritized based on patient, product, and compliance risk.Perform Failure problem identification, resolution, loss reporting and continuous improvementDesign and implement methods for process control, process improvement, testing and inspectionLead continuous improvements and ongoing compliance of the Complaints, Post Market Surveillance, Regulatory Reporting and Risk Management Systems.Develop, execute, and analyze quality reporting measuresLead/Participate the Product Experience Review (PER) and Quality System Management Review for the Post Market Surveillance ProcessCompile quality metrics, QA logs and databases, reports for posts-market activities.QualificationsBS or MS degree in Mechanical, Biomedical, or Manufacturing Engineering2-3+ years of medical device manufacturing/quality engineering experienceStrong knowledge of quality tools used in the industryAnalytical and quantitative approach to problem solvingExcellent written and verbal communication skillsKnowledge of cGMP, FDA 820 QSR and ISO 13485 or other Quality SystemsFull-Time Permanent PositionFull Benefits (Medical, 401K Match, tuition reimbursement)This is an on-site position (NOT Hybrid).Local Candidates preferred, however well-qualified candidates from outside the area may also be considered.US Citizen or candidates with Work Authorization that dont need sponsorship preferred

Created: 2025-02-24