Overview
Quality Engineer Jobs in Ontario, Canada at Intellectt Inc
Title: Quality Engineer
Company: Intellectt Inc
Location: Ontario, Canada
We are seeking a detail-oriented Quality Engineer to ensure product and process quality standards are met. The role involves supporting quality assurance activities, driving continuous improvement, and ensuring compliance with Canadian and international standards such as ISO and regulatory requirements.
Key Responsibilities
- Develop, implement, and maintain Quality Management Systems (QMS) (ISO 9001 / ISO 13485)
- Perform root cause analysis (RCA) using tools like Fishbone, 5 Whys, and FMEA
- Conduct internal audits and support external audits (regulatory & customer)
- Manage non-conformance reports (NCRs) and corrective/preventive actions (CAPA)
- Ensure compliance with Health Canada, FDA (if applicable), and industry regulations
- Review and approve engineering changes, validation, and verification documents
- Support supplier quality management and vendor audits
- Analyze quality data and generate reports using statistical tools (SPC, Minitab)
- Collaborate with cross-functional teams (Production, Design, Validation)
- Drive continuous improvement initiatives (Lean, Six Sigma)
Required Qualifications:
- Bachelor’s degree in Engineering (Mechanical / Electrical / Industrial / Biomedical)
- 3–8+ years of experience in Quality Engineering
- ISO 9001 / ISO 13485
- CAPA, NCR, and audit processes
- Statistical tools (SPC, MSA, Cp/Cpk)
- FMEA, Control Plans, PPAP (automotive preferred)
- Familiarity with regulatory standards (Health Canada, FDA, GMP)
- Certification in Six Sigma (Green Belt / Black Belt)
- Experience in medical device or regulated industry
- Knowledge of risk management (ISO 14971)
