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Quality Assurance Manager (Saudi Nationals Only)

alcon · Saudi Arabia

New
Senior 🇬🇧 English
ISO 13485 GDP 21 CFR Part 820 SAP

Job description

About the role

Alcon is seeking a Saudi national to build and lead its Quality Assurance function in Saudi Arabia. You will establish the Quality System, ensure compliance with global and local regulations, and support rapid market growth.

Key responsibilities

  • Develop and embed a strong Quality Culture across cross‑functional teams.
  • Ensure compliance with ISO 13485, GDP, EU‑MDR (where applicable) and Saudi regulatory requirements.
  • Act as Quality Management Representative and Responsible Person for wholesale distribution.
  • Oversee batch documentation review, product release, storage, distribution, supplier qualification, and management of non‑conformances and CAPAs.
  • Prepare for and manage external inspections by Health Authorities and Notified Bodies.
  • Lead vigilance and technovigilance activities, reporting to local authorities.

Required profile

  • Bachelor’s degree in a scientific or engineering discipline.
  • Minimum 5 years of Quality experience in medical device or pharmaceutical industry.
  • Strong knowledge of ISO 13485 and 21 CFR Part 820.
  • Experience with vigilance/technovigilance processes.
  • Fluency in English and excellent communication skills.
  • People‑management experience is an advantage.
  • Familiarity with Saudi regulatory requirements is highly preferred.

Required skills

  • ISO 13485
  • GDP
  • EU‑MDR
  • 21 CFR Part 820
  • SAP (or similar digital systems)

What we offer

  • Opportunity to build an affiliate Quality function from scratch.
  • Dynamic, fast‑growing market with significant career growth potential.
  • Collaborative international environment with regional leadership exposure.

Questions fréquentes

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Source : ats:workday

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Published 2 weeks ago

Expires 1 month from now

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alcon

Saudi Arabia