Quality Assurance Associate
3 months ago
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 a QA Associate supporting the Africa and Middle East regions, you will be trusted to support all quality activities, ensuring compliance with Alcon corporate and local quality requirements. In this role, a typical day will include:
- Collaborating with cross-functional teams to implement and maintain the Quality Management System (QMS) in line with GxP, regulatory, and quality standards.
- Leading continuous improvement efforts through the identification, follow-up, and closure of Corrective and Preventive Actions (CAPAs).
- Ensuring compliance across the region's Alcon offices, overseeing product handling, storage, and distribution according to labelled, regulatory, and GxP requirements.
- Investigating quality issues and managing local deviations, escalating potential issues to local management and Corporate QA when necessary.
- Managing audits and regulatory inspections, ensuring no critical observations and that all required documentation is completed on time.
- Initiate and review QAA with distributors.
- Support and implement Risk assessment review for New Distributors and current distributors properly and on time.
What You’ll Bring to Alcon:
- Education: BS Degree in Engineering or Scientific discipline required (preferred in a Scientific discipline).
- Experience: Minimum 2 years’ experience in a quality role within a regulated industry (Devices or Drugs), with GxP experience, and knowledge of Distributor Quality management and Quality auditing.
- Technical Skills: Knowledge of GxP, ISO 13485, MDD (as applicable), local regulatory quality requirements, and fluency in English (French is highly recommended). Proficiency with standard software platforms.
- Preferred: Experience as a Quality Auditor and knowledge of Vigilance.
How You Can Thrive at Alcon:
- Autonomy and Impact: Lead quality initiatives across a diverse, multi-country region, making a direct impact on compliance and product safety.
- Challenging Work: Be part of a global organization, ensuring excellence in quality standards and regulatory compliance.
- Collaborative Team Environment: Work with a high-performing team that values innovation, accountability, and continuous improvement.
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