Advance quality assurance at SCIEX through CAPA leadership, document control, and regulatory knowledge in an onsite Concord, Ontario position. Strengthen processes and compliance.

This Quality Systems Specialist supports the maintenance and continuous improvement of SCIEX’s Quality Management System. Reporting to the Senior Manager, QMS, you will work within Quality Assurance and Regulatory Affairs. The position addresses audits, corrective actions, controlled records, training materials, quality-data reporting, and process effectiveness.

Key Responsibilities:
Maintain QMS processes against regulatory and internal requirements
Coordinate audit readiness, responses, action items, and closure
Guide CAPA investigations, action planning, documentation, and verification
Revise procedures, work instructions,



forms, and training materials
Identify improvement opportunities through quality-data trend analysis

Requirements:
Degree in science, engineering, quality assurance, or related field
Three years’ minimum QMS experience in regulated settings
Knowledge of ISO 9001, ISO 13485, and FDA systems
Experience with CAPA, audits, document control, and quality records
Experience writing procedures and reporting quality data

Bring regulated quality assurance experience, CAPA knowledge, and document-control skills to SCIEX’s continuous improvement efforts.

📌 Quality Assurance Qms Specialist Vaughan
🏢 Danaher
📍 Vaughan