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Director of Quality Assurance
1 month ago
TalentSphere Staffing Solutions is partnering with a commercial-stage diagnostics company to find a highly experienced Head of Quality Assurance to lead their Quality Assurance team.
Key Responsibilities:- Lead the Quality Assurance team to maintain compliance with quality standards for Laboratory Developed Tests (LDT) and In Vitro Diagnostics (IVD).
- Manage external audits and corrective actions for MDSAP, ISO, FDA, and other regulatory bodies.
- Support new product development, design controls, and risk management processes.
- Oversee internal audits, non-conformances, CAPA, and customer complaints.
- Identify and implement quality improvements to enhance product and customer satisfaction.
- Act as interim PRRC to ensure compliance with conformity, post-market, and reporting requirements.
- Provide technical training and promote a culture of quality and compliance.
- Master's degree or equivalent with 8+ years in quality assurance/control, including management roles in diagnostics or medical devices.
- Proven experience in managing audits and eQMS platforms.
This is a fantastic opportunity for a seasoned quality professional to join a dynamic team and contribute to the growth of a leading diagnostics company.
