Sr Associate Quality Assurance

Location: Riyadh Saudi Arabia

About Alcon

At Alcon were passionate about enhancing sight and helping people see brilliantly. With more than 25000 associates worldwide we innovate fearlessly champion progress and act swiftly to impact global eye health. We foster an inclusive culture recognizing your contributions and offering opportunities to grow your career like never before. Together we make a difference in the lives of our patients and customers.

The Opportunity

As a Sr Associate Quality Assurance you will play a key role in maintaining and enhancing Alcons Quality Management System while ensuring compliance with global and local regulatory requirements. You will collaborate with cross-functional teams to support quality operations supplier oversight audits investigations and continuous improvement initiatives that help ensure product quality patient safety and operational excellence.

Key Responsibilities

Quality Systems & Compliance

• Drive awareness and effective implementation of the Quality Management System (QMS) across the business.
• Ensure compliance with applicable regulations and standards including GMP GDP ISO 13485 EU-MDR (where applicable) and local regulatory requirements.
• Review and approve quality documentation Quality Assurance Agreements product returns and Annual Product Quality Reviews.
• Support product handling storage distribution and release activities in compliance with regulatory and quality requirements.

Quality Operations

• Support Quality Management System activities including CAPA change control risk management management review quality planning KPI monitoring and SOP compliance.
• Conduct non-conformance investigations and support root cause analysis and corrective/preventive action implementation.
• Raise awareness of quality risks and support timely escalation of quality events when needed.
• Participate in supplier audits self-inspections and supplier qualification activities

Vigilance Management and HA interactions

• Support post-market surveillance activities and ensure compliance with applicable regula-tions.
• Collect review and evaluate post-market data from customers distributors healthcare providers and other sources.
• Act as the primary liaison with SFDA for vigilance-related communications and requests.
• Coordinate responses to SFDA inquiries requests for additional information and inspec-tion observations related to vigilance activities.
• Monitor changes to SFDA vigilance regulations guidance documents and reporting re-quirements.
• Support implementation of regulatory updates within the Quality Management System (QMS).
• Coordinate investigations of complaints and adverse events with internal stakeholders and manufacturers.
• Monitor complaint trends and identify potential safety signals requiring further evaluation.

Continuous Improvement & Stakeholder Collaboration

• Partner with internal stakeholders to support multiple projects while maintaining high standards of quality and compliance.
• Support initiatives that drive operational excellence and achievement of quality KPIs.
• Contribute to continuous improvement programs that strengthen quality performance and business effectiveness.

Qualifications

• Bachelors degree in Pharmacy Life Sciences Engineering Quality Management or a related discipline.
• Experience in Quality Assurance Regulatory Affairs Medical Devices Pharmaceuticals Healthcare or a regulated industry.
• Knowledge of SFDA vigilance and post-market surveillance requirements.
• Understanding of Quality Management Systems including ISO 13485 and applicable reg-ulatory standards.
• Experience supporting audits investigations CAPA processes and supplier quality activities.
• Strong analytical problem-solving and communication skills.
• Ability to collaborate effectively across functions and manage multiple priorities.

What Youll Bring

• Strong attention to detail and commitment to quality and compliance.
• A proactive approach to identifying risks and implementing solutions.
• Excellent stakeholder management and communication skills.
• Ability to work effectively in a fast-paced and highly regulated environment.
• A continuous improvement mindset and passion for operational excellence.

HOW YOU CAN THRIVE AT ALCON

• Make a direct impact on customer satisfaction and patient outcomes.
• Join a collaborative team focused on continuous improvement and operational excellence.
• Develop your expertise within a global healthcare leader.
• Grow your career in an environment that values innovation learning and professional development.

See your impact at Current Alcon Employee/Contingent Worker

If you are currently an active employee/contingent worker at Alcon please click the appropriate link below to apply on the Internal Career site.

Find Jobs for Employees

Find Jobs for Contingent Worker