Senior Specialist QA & PMS

StrykerRiyadh, Riyadh RegionOn-siteFull-timeJunior, 1–2 yearsListed 1 week ago

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About this role

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 the KSA 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.

Travel Percentage: 10%