Senior Specialist QA & PMS
Description
Work Flexibility: Hybrid or Onsite
We are looking for a QA & PMS Specialist to support the implementation and maintenance of Quality Assurance and Post Market Surveillance activities across our MENA organization.
What you will do:
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Executing Quality Assurance (QA) and Post Market Surveillance (PMS) activities in line with local, regional, and corporate procedures and requirements.
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Supporting the implementation and maintenance of the local Quality Management System (QMS) to ensure ongoing regulatory compliance.
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Coordinating product safety reporting activities and supporting communications with relevant stakeholders, including healthcare professionals, distributors, and regulatory authorities.
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Supporting the management of quality events, including non-conformances (NCs), corrective and preventive actions (CAPAs), and follow-up activities.
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Assisting in the development, update, and implementation of quality procedures, work instructions, and SOPs.
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Participating in internal and external audits and supporting inspection readiness activities.
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Delivering quality and compliance training to employees and supporting onboarding of new team members.
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Working cross-functionally to ensure quality requirements are effectively integrated into business processes.
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Supporting the implementation of regional or global quality system changes within the local organization.
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Monitoring, collecting, and reporting QA and PMS metrics and supporting continuous improvement initiatives.
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Promoting a culture of quality and compliance across the organization.
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Collaborating with EEMEA and global RAQA teams to support business and regulatory objectives.
What you need:
Required
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Bachelor’s degree in Engineering, Life Sciences, Healthcare, or a related field.
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1-3 years of experience in Quality Assurance, Regulatory Affairs, Post Market Surveillance, or a related healthcare or medical device environment.
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Knowledge of Quality Management Systems and regulatory compliance principles.
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Strong organizational, communication, and problem-solving skills.
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Proficiency in Microsoft Office applications.
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Fluency in English.
Preferred
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Experience within the medical device, pharmaceutical, or healthcare industry.
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Familiarity with NC, CAPA, complaint handling, or PMS processes.
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Knowledge of ISO 13485, MDR, SFDA, or other applicable quality and regulatory requirements.
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Arabic language skills are an advantage.
Travel Percentage: 10%