Director of Quality Assurance

1 month ago


Vancouver, British Columbia, Canada TalentSphere Staffing Solutions Full time
Quality Assurance Leadership Opportunity

TalentSphere Staffing Solutions is seeking a highly experienced Quality Assurance Director to lead the Quality Assurance team and ensure compliance with quality standards for Laboratory Developed Tests (LDT) and In Vitro Diagnostics (IVD).

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 the Company:

TalentSphere Staffing Solutions is a commercial-stage diagnostics company focused on autoimmune disorders to personalize and optimize treatment for patients globally. They are building a values-driven organization committed to transforming illness into wellness.



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