Sr. Director, Quality Leadership Team (QLT)
Sr. Director, Quality Leadership Team (QLT)
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Salary Not Disclosed
1 Vacancy
Job Description
At Alcon were passionate about enhancing sight and helping people see brilliantly. With more than 25000 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 Alcons 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.
The Sr. Director Quality Leadership Team (QLT) (Management Path) is primarily responsible for leading the total quality function of a plant or group of plants ensuring compliance with quality policies Standard Operating Procedures (SOPs) and regulations. You will ensure 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. Specifics 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 regulations
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.
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.
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Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion gender national origin age sexual orientation gender identity marital or veteran status disability or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of a position please send an email to and let us know the nature of your request and your contact information.
Required Experience:
Director
Employment Type
Full-Time
