Additional Information
At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you'll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon.
As Associate II, Quality Assurance Compliance , you will support the implementation and maintenance of the Quality Management System (QMS) at Alcon Singapore, ensuring alignment with Alcon standards and policies, as well as applicable customer and regulatory requirements. You will be responsible for ensuring inspection readiness, data integrity, training compliance, and the effective operation of end-to-end quality systems, in line with global standards, regulatory expectations, and internal policies.
In this role, a typical day will include:
- Support inspection readiness activities, including preparation for internal audits and regulatory inspections (e.g., Health Authorities, Notified Bodies)
- Coordinate and track responses to inspection observations, ensuring timely closure
- Review and approve change controls, ensuring compliance with regulatory expectations
- Ensure adherence to GMP, ISO 13485, MDSAP, EU MDR, and local regulatory requirements (e.g., HSA)
- Manage and oversee the site training program, including monitoring completion, addressing gaps, and maintaining training records in an inspection-ready state
- Support training-related activities during audits and inspections
- Support Data Integrity initiatives and promote compliance with ALCOA+ principles
- Compile and analyze quality metrics, and support Management Review reporting
- Coordinate and prepare Annual Product Quality Review (APQR) reports
- Support document control and artwork review processes
- Identify opportunities for continuous improvement in quality systems
WHAT YOU'LL BRING TO ALCON:
- Knowledge of GMP and ISO 13485 quality systems, Regulatory frameworks (e.g., HSA, EU MDR, MDSAP) and Data integrity principles (ALCOA+)
- Strong attention to detail and a compliance-focused mindset
- Effective communication and stakeholder management skills
- Proactive, organized, and action-oriented approach
Alcon · Tuas, Singapore