Senior Specialist QA & PMS

Role Overview

Senior Specialist QA & PMS at Stryker. MENA organization. Hybrid or onsite work flexibility.

Role Purpose

Support the implementation and maintenance of Quality Assurance and Post Market Surveillance activities across the MENA organization in line with local, regional, and corporate procedures and requirements.

Key Responsibilities

Quality Assurance & Post Market Surveillance

• Execute Quality Assurance and Post Market Surveillance activities in alignment with local, regional, and corporate procedures and requirements.
• Monitor, collect, and report QA and PMS metrics.
• Support continuous improvement initiatives.

Quality Management System

• Support the implementation and maintenance of the local Quality Management System to ensure ongoing regulatory compliance.
• Supporting the implementation of regional or global quality system changes within the local organization.

Product Safety & Stakeholder Management

• Coordinate product safety reporting activities.
• Support communications with relevant stakeholders, including healthcare professionals, distributors, and regulatory authorities.

Quality Events Management

• Support the management of quality events, including non-conformances, corrective and preventive actions, and follow-up activities.

Quality Documentation & Procedures

• Assist in the development, update, and implementation of quality procedures, work instructions, and standard operating procedures.

Audits & Compliance

• Participate in internal and external audits.
• Support inspection readiness activities.

Training & Development

• Deliver quality and compliance training to employees.
• Support onboarding of new team members.

Cross-functional Collaboration

• Work cross-functionally to ensure quality requirements are effectively integrated into business processes.
• Collaborate with EEMEA and global RAQA teams to support business and regulatory objectives.
• Promote a culture of quality and compliance across the organization.

Qualifications & Experience

• 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.

Skills & Competencies

• Strong organizational skills.
• Strong communication skills.
• Strong problem-solving skills.
• Proficiency in Microsoft Office applications.
• Fluency in English.
• Arabic language skills (preferred).

Additional Information

• Travel: 10%.
• Experience within the medical device, pharmaceutical, or healthcare industry (preferred).
• Familiarity with non-conformance, corrective and preventive actions, complaint handling, or Post Market Surveillance processes (preferred).
• Knowledge of ISO 13485, MDR, SFDA, or other applicable quality and regulatory requirements (preferred).