Senior QMS Quality Engineer Medical Devices
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Maintain QMS compliance with FDA QMSR, ISO 13485, and Health Canada regulations Administer eQMS workflows, upgrades, validation, reports, and dashboards Lead CAPA, nonconformance, deviation, and change control processes Support internal audits, inspections, certification audits, and corrective actions Develop quality metrics and recommend system improvements Requirements:
Bachelor's degree in engineering, biomedical engineering, life sciences, quality, or related discipline Seven years of Quality Engineering or Quality Systems experience in medical devices Five years maintaining QMS compliant with ISO 13485 and FDA requirements Experience administering eQMS and supporting audits or inspections Diagnostics, IVD, or point-of-care experience strongly preferred Bring senior QMS leadership, eQMS administration, audit readiness, and medical device quality expertise to this onsite assignment.
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