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Job Description & How to Apply Below
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.
- 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.
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