Senior Specialist QA & PMS

Stryker; Riyadh; Hybrid; SAR 150,000 - 230,000; Full time

Job summary

Stryker is seeking a QA and PMS Specialist to support quality assurance and post-market surveillance activities across the MENA region. The role ensures regulatory compliance and effective COE operations, with hybrid or onsite flexibility in Riyadh area.

You will coordinate safety reporting, assist in QMS maintenance, and drive continuous improvement while collaborating with RAQA and global teams. English fluency is required.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Healthcare or related field.
• 1–3 years of experience in Quality Assurance, regulatory affairs, PMS or related healthcare environment.
• Knowledge of Quality Management Systems and regulatory compliance principles.

Responsibilities

• Execute QA and PMS activities following local, regional and corporate procedures.
• Support the local QMS implementation and regulatory compliance.
• Coordinate product safety reporting with stakeholders and authorities.
• Support management of quality events including NCs and CAPAs.
• Assist in developing and updating quality procedures and SOPs.
• Participate in audits and inspection readiness activities.
• Deliver quality training and support onboarding of new staff.
• Work cross-functionally to embed quality in processes.
• Support regional/global quality system changes locally.
• Monitor QA and PMS metrics and drive continuous improvement.
• Promote a culture of quality and compliance.

Skills

Quality Assurance

Post Market Surveillance

Regulatory Affairs

SOPs & QMS

Cross-functional collaboration

Education

Bachelor's degree in Engineering/Life Sciences/Healthcare or related field

Tools

MS Office

Job description

Work Flexibility Hybrid or Onsite

We are looking for a QA amp 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

• 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