Support ISO-compliant quality systems at SCIEX in Concord, Ontario, using audit coordination, CAPA expertise, and eQMS administration onsite. Help strengthen inspection readiness.

As a Quality Systems Specialist, you will maintain and improve the SCIEX Quality Management System within the Quality Assurance and Regulatory Affairs Team. The position supports compliance with ISO 9001, ISO 13485, FDA quality-system requirements, and other applicable requirements. Your work spans audits, controlled documentation, training, quality metrics, and continuous improvement.

Key Responsibilities:

- Support internal and external audit planning, execution, responses, and closure
- Administer eQMS documents, records, assignments, reports, and procedures
- Guide audit and CAPA owners through investigations and effectiveness verification
- Monitor quality metrics,



trends, dashboards, and significant compliance risks
- Support software validation and cross-functional QMS improvement projects

Requirements:

- Bachelor’s degree or equivalent education and experience
- At least three years of quality assurance or QMS experience
- Working knowledge of ISO 9001, ISO 13485, and FDA requirements
- Experience supporting audits, CAPA, document control, and quality records
- Experience with eQMS applications, procedure writing, and quality reporting

Apply quality systems, audit, CAPA, and eQMS experience to support SCIEX compliance and inspection readiness in Concord.

📌 Quality Management Systems Specialist (Vaughan)
🏢 Danaher
📍 Vaughan