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 the Sr. Director, Quality Leadership Team (QLT), you will lead the total quality function of a plant or group of plants, ensuring compliance with quality policies, Standard Operating Procedures (SOPs), and regulations. You will be responsible for the quality of materials, oversee training, and implement an effective Quality Management System. As the local Management Representative and ISO Deputy, you will ensure compliance with Quality System Standards and Regulations.
In this role, a typical day will include:
Manage and direct Quality Assurance Departments, including Quality Systems, Documentation Control, Quality Control, Quality Engineering, Regulatory Affairs, Complaint Handling, and Laboratory Services- Ensure compliance with European Union Medical Device Regulation (EU MDR) 2017/745 and meet experience requirements per Medical Device Coordination Group (MDCG) 2019-07
- Provide direction on quality systems and tools, focusing on process improvements
- Perform duties as Facility Management Representative to ensure effective Quality System implementation
- Maintain compliance with Food and Drug Administration (FDA) Quality System Regulations (QSRs), ISO 13485, Medical Device Directive (MDD), Medical Device Regulation (MDR), and ISO 14000 standards
- Report on quality system performance and improvement needs
- Promote regulatory and customer requirements awareness throughout the organization
- Implement systems to prevent product recalls and manage postmarket surveillance actions
- Maintain responsibility for product sterility systems and product release
- Oversee product registration and maintain current registrations
- Manage a suitably resourced Quality Assurance Department with qualified personnel
- Promote cooperation and teamwork through open communication and coordination
- Identify potential successors for key positions and develop readiness plans
- Identify future budgetary requirements and manage Quality Assurance budget within targets
- Ensure Quality Management System compliance with Medical Device Single Audit Program (MDSAP) requirements and support certification efforts
- Adhere to Good Practice (GxP) regulations, maintain accurate documentation, and complete required training
- For Belgium, act as the Responsible Person for distribution activities in Puurs and Bornem warehouse, ensuring compliance with Benelux, European, United States, and other international regulationsAll 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.
WHAT YOU'LL BRING TO ALCON:
- Degree in pharmacy, engineering or another relevant scientific discipline, and at
- least one year of professional experience in regulatory affairs or in quality management systems
- relating to medical devices
- Experience: Min 15 years of professional experience in regulatory affairs or in quality management systems relating to medical devices with 5 years in a leadership role
HOW YOU CAN THRIVE AT ALCON:
- Join a global leader with a rich history of innovation and excellence in eye care.
- Be part of a collaborative and supportive team culture that values diversity and inclusion.
- Enjoy a competitive compensation package and opportunities for career advancement.
- Make a meaningful difference in the lives of patients worldwide by contributing to cutting-edge advancements in eye health.
Alcon Careers
See your impact at alcon.com/careers
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.
