We're seeking a detail-oriented Quality Systems Specialist to drive excellence in quality processes and continuous improvement. This role focuses on analyzing current systems, implementing process enhancements, and ensuring compliance with ISO 13485/MDSAP standards.
Key Responsibilities
Lead and improve core Quality System processes: inspections, NCR, CAR/CAPA, and Device History Records.
Investigate product/process issues and manage non-conformance and corrective actions.
Analyze data, generate KPI reports, and support data-driven decision-making.
Facilitate part approval processes (PPAP, supplier changes) and support internal audits.
Ensure compliance with health and safety regulations.
What You Bring
Degree/Diploma in Engineering or related field.
5+ years in quality systems, process improvement, or medical device manufacturing.
Knowledge of ISO 13485, GMP, GDP, and eQMS systems.
Strong analytical, organizational, and communication skills.
Proficiency in MS Office and project management tools.
Quality certifications (CQE, CQA, CMQ) and audit experience are assets.
•
