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Senior Director of Quality Assurance
1 month ago
Are you a seasoned quality assurance professional looking to take on a leadership role in a dynamic diagnostics company? We are seeking a highly experienced Senior Director of Quality Assurance to lead our Quality Assurance team in ensuring compliance with quality standards for our Laboratory Developed Tests (LDT) and In Vitro Diagnostics (IVD).
This role will collaborate with cross-functional teams to drive continuous improvement and support product expansion initiatives. The ideal candidate will have a Master's degree or equivalent with 8+ years in quality assurance/control, including management roles in diagnostics or medical devices.
Key responsibilities include:
- Leading the Quality Assurance team to maintain QMS compliance with MDSAP, ISO, GxP, and other standards.
- Managing external audits and corrective actions for MDSAP, ISO, FDA, and other regulatory bodies.
- Supporting new product development, design controls, and risk management processes.
- Overseeing internal audits, non-conformances, CAPA, and customer complaints.
- Identifying and implementing quality improvements to enhance product and customer satisfaction.
- Acting as interim PRRC to ensure compliance with conformity, post-market, and reporting requirements.
- Providing technical training and promoting a culture of quality and compliance.
The candidate must have the authority to work in Canada and be able to work independently in a dynamic, fast-paced environment. A benefits package is available.
