Senior Specialist QA & PMS

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:

• Bachelors 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.