Sr Associate, Quality Assurance

The Opportunity

Quality Systems and Compliance

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

Quality Operations

• Support 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 and preventive action implementation.
• Raise awareness of quality risks and support timely escalation of quality events.
• Participate in supplier audits, self-inspections, and supplier qualification activities.

Vigilance and Health Authority Interactions

• Support post-market surveillance and evaluate data from customers, distributors, healthcare providers, and other sources.
• Act as the primary liaison with SFDA for vigilance communications and requests.
• Coordinate responses to SFDA inquiries, information requests, and vigilance-related inspection observations.
• Monitor SFDA vigilance regulations, guidance, and reporting requirements.
• Coordinate complaint and adverse-event investigations and monitor trends for potential safety signals.

Continuous Improvement

• Partner with internal stakeholders on multiple quality and compliance projects.
• Support initiatives that improve operational excellence and quality KPI performance.
• Contribute to continuous improvement programs that strengthen quality performance and business effectiveness.

Qualifications

• 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 another regulated industry.
• Knowledge of SFDA vigilance and post-market surveillance requirements.
• Understanding of Quality Management Systems, including ISO 13485 and applicable regulatory standards.
• Experience supporting audits, investigations, CAPA processes, and supplier quality activities.
• Strong analytical, problem-solving, communication, collaboration, and prioritization skills.

About Alcon