Sr Associate, Quality Assurance

At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 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.

As a Sr Associate, Quality Assurance, you will play a key role in maintaining and enhancing Alcon’s 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.

• 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.

• 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

• 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.

• 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.

• Bachelor’s 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.

• 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.

• 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.

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