Medical Device Quality Assurance Expert
7 days ago
Contribute to the development of safe and effective medical devices at Intellijoint Surgical Inc., a leading provider of innovative surgical solutions.
This is a full-time position based in Kitchener HQ, requiring an in-office presence for 3 days per week. Benefits include RRSP with employer match, health benefits from day one, wellness benefit, learning & development opportunities, paid vacation, personal days, and sick days.
A Quality Assurance Analyst will be responsible for supporting design, production, and process quality. The role entails maintaining the quality management system, ensuring compliance with industry standards and regulatory requirements, and contributing to the creation of innovative technologies that enhance surgeons' care and patients' lives.
Main duties:
- Manage quality issues, including Corrective and Preventative Actions, Deviations, Non-Conformances, etc.
- Coordinate cross-functional stakeholders to document, investigate, and close complaints
- Provide Operations support for timely product release and shipment
- Maintain production processes according to requirements
- Perform quality assurance activities related to audits, training, change control, document and record management
- Analyze sources of quality data to identify problem trends and opportunities for improvement
The ideal candidate has a Post-Graduate diploma in Quality Assurance (an asset) and 3-5 years of relevant quality management experience in a regulated industry. Knowledge of Medical Device standards (ISO 13485, MDSAP, ISO 14971, IEC 60601) and working knowledge of root cause analysis tools are required.
The estimated salary for this position is around $70,000 - $90,000 per year, depending on experience. If you have a passion for quality assurance and a desire to work with innovative medical devices, please apply.
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