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Quality Assurance Director
1 month ago
Are you a seasoned quality assurance professional looking to take your career to the next level? Do you have a passion for ensuring compliance with quality standards and regulations? We are seeking a highly experienced Quality Assurance Director to lead our Quality Assurance team and drive quality excellence in our diagnostics company.
Key Responsibilities:- Lead the Quality Assurance team to maintain QMS compliance with MDSAP, ISO, GxP, and other standards.
- 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.
Requirements:
- 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.
About Our Company:
TalentSphere Staffing Solutions is a commercial-stage diagnostics company focused on autoimmune disorders to personalize and optimize treatment for patients globally. We are building a values-driven organization committed to transforming illness into wellness.
