Director of Quality Assurance

1 month ago

Vancouver, British Columbia, Canada TalentSphere Staffing Solutions Full time
Job Title: Associate Director, Quality Assurance

Are you a seasoned quality assurance professional looking to take your career to the next level? Do you have a passion for ensuring compliance and driving quality excellence in a dynamic and fast-paced environment?

Job Summary:

We are seeking a highly experienced Associate Director, Quality Assurance to join our team. As a key member of our quality assurance department, you will be responsible for leading the quality assurance team, ensuring compliance with quality standards for our Laboratory Developed Tests (LDT) and In Vitro Diagnostics (IVD). This role collaborates with cross-functional teams to drive continuous improvement and supports product expansion initiatives.

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.
  • Expertise in MDSAP, ISO 13485, ISO 14971, CFR 820, and related regulations.
  • Proven experience in managing audits and eQMS platforms.
  • Strong leadership, problem-solving, and superior communication skills.
  • Ability to work independently in a dynamic, fast-paced environment.

The ideal candidate will have a strong background in quality assurance and a passion for driving quality excellence. If you are a motivated and experienced professional looking to take your career to the next level, we encourage you to apply for this exciting opportunity.

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