Senior Specialist QA

منذ 3 ساعات

Riyadh, Riyadh Province, المملكة العربية السعودية Stryker دوام كامل
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:

  • 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.

Travel Percentage: 10%


Required Experience:

Senior IC


Employment Type : Full-Time
Experience: years
Vacancy: 1