Apply on Kit Job: kitjob.ca/job/2fsjxv

This position is open exclusively to people who are eligible to work in USA

Overview

We are seeking a Quality Assurance Engineer to support quality systems and ensure compliance in regulated environments. The role focuses on maintaining product quality, supporting audits, and driving continuous improvement initiatives.

Required Experience

- 2-4 years of experience in Quality Assurance within Pharma / Medical Device / Life Sciences industry
- Solid knowledge of GMP and FDA regulations (21 CFR Part 11 / 21 CFR Part 820)
- Experience with deviation, CAPA, and change control processes
- Hands-on experience with quality documentation and audits
- Knowledge of ISO 13485 and/or ISO 9001 standards

Key Responsibilities

- Ensure compliance with GMP, FDA, and quality standards
- Manage and review deviations, CAPA, and change control records
- Support internal and external audits and regulatory inspections
- Review and approve quality documentation including SOPs and reports
- Conduct root cause analysis and implement corrective/preventive actions

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Apply on Kit Job: kitjob.ca/job/2fsjxv

📌 Quality Assurance Engineer (Edmonton)
🏢 Shoolin
📍 Edmonton