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Head of Quality Assurance

2 months ago

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

Are you a seasoned quality assurance professional looking to take your career to the next level? We have an exciting opportunity for a Head of Quality Assurance to join our team at TalentSphere Staffing Solutions.

Job Summary

We are seeking a highly experienced and skilled quality assurance professional to lead our quality assurance team. As Head of Quality Assurance, you will be responsible for 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.

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 proven track record of leading teams to achieve quality excellence. If you are a motivated and results-driven professional looking for a new challenge, please submit your application.

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are interested in this exciting opportunity, please submit your resume and cover letter.