At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, 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. Are you ready to join us?
This role is part of Alcon's Quality & Regulatory Affairs function, a team that ensures our products are in compliance with global, local, and internal regulations and meet the strictest standards of quality as we help people see brilliantly.
Associate, Quality Assurance, is primarily responsible, to perform complaint sample verifications and complete documentation related to complaint sample verifications. Conduct regular equipment standardizations. Develop, review and revise SOPs, Forms, and Wis. Identify and investigate nonconformances. Generate and execute CAPAs as needed. Execute special projects assigned, ensuring compliance with quality standards by monitoring systems, performing audits, identifying issues, and assisting in corrective actions.
Job responsibilities:
• Inspections of complaint samples are accomplished per SOP and quality standards, while meeting the productivity thresholds.
• Ensure instruments are compliant with calibration / verification requirements as stated by Alcon and/or manufacturer guidelines.
• Assigned NCRs are adequately investigated and CAPA’s are appropriately identified and completed on time.
• Interacts with internal and external contacts to provide clear, straightforward, effective, and factual communication and information.
• Responsible in new equipment qualification.
• Maintains awareness of the roles of immediate team members and the work function.
• Responsible to adhere to the Alcon Code of Business Conducts and Alcon Health, Safety and Environment Standards.
• Responsible to observe and ensure full compliance with Information security policy.
• Apply specialized knowledge to support project goals and ensure compliance with established quality standards
• Monitor systems and processes, perform audits and inspections, and identify issues
• Assist in implementing corrective actions to maintain product quality and safety
• Follow procedures with decision-making authority, requiring job-related training and attention to detail
• Ensure products and processes meet established quality standards and customer requirements
• Adhere to Good Practice (GxP) regulations by strictly following Standard Operating Procedures (SOPs)
• Maintain accurate and complete documentation, ensuring rigorous quality control
• Complete all required training and meet individual job requirements
• Contribute to the overall compliance of the organization by committing to continuous improvement and adherence to regulatory requirements.
• All associates must adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training.
• Associates are responsible for meeting their individual job requirements and contributing to the overall compliance of the organization.
• Compliance with regulatory requirements and a commitment to continuous improvement are essential to our operations.
Minimum Requirements:
• Education: Bachelor degree in Engineering or Science.
• Experience: Minimum 0-3 years working experiences in Quality division and preferably those has experiences working in Medical Device or Pharmaceutical Industries
Key Performance Indicators
Completion of tasks accurately and in time to meet department deadlines and internal and external customer needs i.e.:-
• Samples verification completion – zero overdue
• Samples delivery to AVS/FTW – as per estimate arrival plan
• Analyst qualification completion – within 3 months upon assigned
• New Equipment Qualification completion – within project timeline
ATTENTION: 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.