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Quality Assurance Specialist
2 months ago
Job Title: Quality Assurance Specialist
About Intellijoint Surgical: Intellijoint Surgical is a medical device company dedicated to developing innovative products that improve surgical outcomes and enhance patients' quality of life. We are a highly talented and driven team that values transparency, collaboration, and innovation.
The Position:
The Quality Assurance Specialist will play a crucial role in supporting design, production, and process quality at Intellijoint Surgical. Responsibilities include maintaining the quality management system to ensure compliance with industry standards and regulatory requirements, as well as ensuring the safety and effectiveness of our products.
Key Responsibilities:
- Execute quality control activities to ensure product quality and regulatory compliance
- Maintain, approve, and create quality documentation, including procedures, protocols, and records
- Support quality onboarding of staff, including training and development programs
- Assist with document control systems, including version control and change management
- Document and track employee training, including quality awareness and regulatory compliance
- Maintain quality dashboards and metrics to track performance and identify areas for improvement
- Coordinate quality issues, including root cause analysis and corrective action
- Facilitate internal and external audits, including preparation and follow-up
- Review and approve product records, including design, development, and manufacturing
- Participate in continuous improvement activities, including process optimization and innovation
- Submit and maintain regulatory documentation, including submissions and responses
Requirements:
- Post-secondary diploma in a relevant field, such as quality assurance, regulatory affairs, or a related discipline
- 1-2 years of experience in a regulated industry, preferably in a quality assurance or regulatory affairs role
- Strong communication skills and attention to detail, with the ability to work effectively in a team environment
- Experience in a medical device environment is an asset, as is familiarity with MS Office, Google Workspace, and Atlassian
Why Work with Us:
- Opportunity to work on innovative medical devices that improve patient outcomes
- Collaborative and dynamic work environment that values transparency and innovation
- Professional development and growth opportunities, including training and mentorship
- Flexible work arrangements to support work-life balance