Senior Specialist QA & PMS
Full time · Posted 12D AGO
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:
Executing Quality Assurance (QA) and Post Market Surveillance (PMS) activities in line with local, regional, and corporate procedures and requirements.
Supporting the implementation and maintenance of the local Quality Management System (QMS) to ensure ongoing regulatory compliance.
Coordinating product safety reporting activities and supporting communications with relevant stakeholders, including healthcare professionals, distributors, and regulatory authorities.
Supporting the management of quality events, including non-conformances (NCs), corrective and preventive actions (CAPAs), and follow-up activities.
Assisting in the development, update, and implementation of quality procedures, work instructions, and SOPs.
Participating in internal and external audits and supporting inspection readiness activities.
Delivering quality and compliance training to employees and supporting onboarding of new team members.
Working cross-functionally to ensure quality requirements are effectively integrated into business processes.
Supporting the implementation of regional or global quality system changes within the local organization.
Monitoring, collecting, and reporting QA and PMS metrics and supporting continuous improvement initiatives.
Promoting a culture of quality and compliance across the organization.
Collaborating with EEMEA and global RAQA teams to support business and regulatory objectives.
What you need:
Required:
Bachelor’s degree in Engineering, Life Sciences, Healthcare, or a related field.
1-3 years of experience in Quality Assurance, Regulatory Affairs, Post Market Surveillance, or a related healthcare or medical device environment.
Knowledge of Quality Management Systems and regulatory compliance principles.
Strong organizational, communication, and problem-solving skills.
Proficiency in Microsoft Office applications.
Fluency in English.
Preferred:
Experience within the medical device, pharmaceutical, or healthcare industry.
Familiarity with NC, CAPA, complaint handling, or PMS processes.
Knowledge of ISO 13485, MDR, SFDA, or other applicable quality and regulatory requirements.
Arabic language skills are an advantage.
