Overview
Quality Engineer Jobs in Ontario, Canada at Intellectt Inc
Title: Quality Engineer
Company: Intellectt Inc
Location: Ontario, Canada
Job Title: Quality Engineer
Location: ON, Canada
Duration: 12 Months
Job Summary:
We are seeking a detail-oriented and proactive Quality Engineer to support quality assurance and compliance activities within a regulated medical device manufacturing environment. The ideal candidate will have hands-on experience with quality systems, process improvements, and regulatory compliance, and will play a key role in ensuring products meet customer and regulatory requirements.
Key Responsibilities:
- Support and maintain the Quality Management System (QMS) in compliance with ISO 13485 and applicable regulatory standards
- Participate in CAPA (Corrective and Preventive Action) investigations and ensure timely closure
- Conduct root cause analysis using tools such as 5 Whys, Fishbone, or Fault Tree Analysis
- Assist with internal and external audits, including regulatory inspections
- Review and approve quality documentation including SOPs, work instructions, and technical reports
- Support process validation activities (IQ/OQ/PQ) and ensure proper documentation
- Monitor and analyze quality metrics, identifying trends and driving continuous improvement initiatives
- Collaborate with cross-functional teams including Manufacturing, R&D, and Regulatory Affairs
- Support supplier quality management, including supplier evaluations and audits
- Ensure compliance with Health Canada, FDA, and other applicable regulations
Required Qualifications:
- Bachelor’s degree in Engineering (Biomedical, Mechanical, Industrial, or related field)
- Minimum 3+ years of experience in a quality engineering role within the medical device or regulated industry
- Working knowledge of:
- ISO 13485
- FDA 21 CFR Part 820
- Good Documentation Practices (GDP)
- Experience with CAPA, non-conformance, and audit processes
- Strong problem-solving and analytical skills
- Excellent written and verbal communication skills
Preferred Qualifications:
- Experience with process validation (IQ/OQ/PQ)
- Knowledge of risk management (ISO 14971)
- Familiarity with statistical tools (Minitab or similar)
- Experience with supplier quality engineering
- ASQ Certified Quality Engineer (CQE) is a plus
