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

Stryker; Riyadh; Hybride; SAR 60 000 - 120 000; Plein temps

Avantages offerts par ce poste

Hybrid work arrangement

Travel opportunities

Résumé du poste

Stryker in Riyadh, Saudi Arabia, is seeking a Senior Specialist, QA & PMS to support Quality Assurance and Post Market Surveillance across the MENA region. You will help ensure product safety, regulatory compliance, and continuous improvement by implementing QMS provisions and coordinating with healthcare professionals, distributors, and authorities.

The role requires cross-functional collaboration, audits, training, and ensuring inspection readiness.

Qualifications

• Bachelor's degree required in engineering, life sciences, healthcare, or related field.
• 1–3 years in QA, regulatory affairs, PMS, or related healthcare/medical devices.
• Knowledge of QMS and regulatory compliance principles.
• Strong organizational, communication, and problem-solving skills.

Responsabilités

• Execute QA and PMS activities per local, regional, and corporate procedures.
• Support the local QMS implementation and regulatory compliance.
• Coordinate product safety reporting with stakeholders and authorities.
• Manage quality events: NCs, CAPAs, and follow-ups.
• Develop, update, and implement quality procedures and SOPs.
• Participate in audits and inspection readiness activities.
• Deliver quality/compliance training and onboard new staff.
• Collaborate cross-functionally to integrate quality into processes.
• Support regional/global quality system changes.
• Monitor QA/PMS metrics and drive continuous improvement.
• Promote a culture of quality and compliance.

Connaissances

Quality Assurance

Regulatory Affairs

PMS processes

Documentation

MS Office

English fluency

Formation

Bachelor's degree in Engineering, Life Sciences, Healthcare

Outils

MS Office

Description du poste

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.

At Stryker, one of the world's leading medical technology companies, we are passionate about making healthcare better and improving patient outcomes. By joining us, you will become part of a diverse, international team where collaboration, innovation and continuous improvement make a real difference.

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.

Additional Information

• Location: Riyadh, Saudi Arabia.
• Working arrangement: Hybrid, on-site three days per week.
• Travel: Approximately 10%, including travel across the MENA region and internationally.