Senior Specialist, Quality Assurance & Post Market Surveillance (QA & PMS)

Job description

As a Senior Specialist, QA & PMS, you will play a key role in supporting Quality Assurance and Post Market Surveillance activities across our MENA organization, ensuring the quality, safety and compliance of our products. You will become part of a diverse, international team where collaboration, innovation and continuous improvement make a real difference. You will execute Quality Assurance (QA) and Post Market Surveillance (PMS) activities in line with local, regional, and corporate procedures and requirements. You will support the implementation and maintenance of the local Quality Management System (QMS) to ensure ongoing regulatory compliance. You will coordinate product safety reporting activities and support communications with relevant stakeholders, including healthcare professionals, distributors, and regulatory authorities. You will support the management of quality events, including non-conformances (NCs), corrective and preventive actions (CAPAs), and follow-up activities. You will assist in the development, update, and implementation of quality procedures, work instructions, and SOPs. You will participate in internal and external audits and support inspection readiness activities. You will deliver quality and compliance training to employees and support onboarding of new team members. You will work cross-functionally to ensure quality requirements are effectively integrated into business processes. You will monitor, collect, and report QA and PMS metrics and support continuous improvement initiatives. You will promote a culture of quality and compliance across the organization. You will collaborate with EEMEA and global RAQA teams to support business and regulatory objectives.

Requirements

• 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

Skills