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Quality Assurance Specialist

Vitrolife Group · Riyad

جديد
Mid 🇬🇧 English
QMS LIS Document control CAPA Risk assessment SFDA regulations CBAHI standards ISO 15189 CAP accreditation

وصف الوظيفة

About the role

We are seeking a Quality Assurance Specialist to strengthen and advance our local quality operations in Riyadh. The role sits at the intersection of regulatory excellence, operational quality, and continuous improvement, ensuring our laboratory services meet the highest international and local standards.

Key responsibilities

  • Oversee day‑to‑day quality activities and ensure compliance with MOH, SFDA, CBAHI and other regulations.
  • Maintain accurate quality records, manage document control, and support updates of local and global procedures.
  • Plan and conduct internal audits, manage findings, and drive CAPA implementation.
  • Support external audits and regulatory inspections, and lead local risk assessments.
  • Investigate deviations, monitor KPIs, incidents and non‑conformities, and report trends to regional quality management.
  • Monitor regulatory changes, support licensing, certifications and renewals, and ensure quality alignment for new services.
  • Train and support staff on quality and regulatory requirements and evaluate external suppliers and referral laboratories.
  • Contribute to regional and global quality initiatives and harmonisation efforts.

Required profile

  • Bachelor’s degree in Laboratory Sciences, Biomedical Sciences or a related field.
  • 3–4 years of experience in a QA/regulatory role within a laboratory or medical environment.
  • Strong knowledge of MOH and SFDA regulations and CBAHI standards; familiarity with ISO 15189 and CAP accreditation is a plus.
  • SCFHS license (preferred) and certification in Quality Assurance or Regulatory Affairs (a plus).

Required skills

  • Quality Management System (QMS) implementation and documentation.
  • Laboratory Information System (LIS) usage.
  • Document control and audit management.
  • CAPA and deviation handling processes.
  • Risk assessment and continuous improvement methodologies.
  • Regulatory knowledge: MOH, SFDA, CBAHI, ISO 15189, CAP.

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Vitrolife Group

Riyad