Quality Management Systems Specialist
SCIEX
Quality management systems expertise meets regulated life sciences at SCIEX in Concord, Ontario, through an on-site Quality Systems Specialist role.This specialist supports SCIEX’s Quality Management System across ISO 9001, ISO 13485, FDA requirements, and internal standards. The position works within Quality Assurance & Regulatory Affairs, reporting to the Senior Manager, QMS. Responsibilities span audits, CAPA, document control, training, eQMS administration, quality metrics, and continuous improvement.Key Responsibilities:
Maintain and improve QMS processes and regulatory complianceSupport audit planning, execution, responses, and action closureAdminister eQMS documents, records, assignments, and reportsGuide audit and CAPA owners through investigationsMonitor metrics, trends, dashboards, and compliance risksRequirements:
Bachelor’s degree or equivalent education and experienceThree years of quality assurance or QMS experienceWorking knowledge of ISO 9001 and ISO 13485Experience with audits, CAPA, document control, and recordsExperience with eQMS, procedure writing, and reportingApply quality systems, audit, CAPA, and eQMS expertise to strengthen compliance at SCIEX in Concord.
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Maintain and improve QMS processes and regulatory complianceSupport audit planning, execution, responses, and action closureAdminister eQMS documents, records, assignments, and reportsGuide audit and CAPA owners through investigationsMonitor metrics, trends, dashboards, and compliance risksRequirements:
Bachelor’s degree or equivalent education and experienceThree years of quality assurance or QMS experienceWorking knowledge of ISO 9001 and ISO 13485Experience with audits, CAPA, document control, and recordsExperience with eQMS, procedure writing, and reportingApply quality systems, audit, CAPA, and eQMS expertise to strengthen compliance at SCIEX in Concord.
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Vacancy posted 2 hours ago
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