Sr. Director, Quality Leadership (QLT)

Alcon MX; United States; Vor Ort; USD 180.000 - 240.000; Vollzeit

Benefits dieser Stelle

Health insurance

Life insurance

Retirement plan

Flexible time off

Zusammenfassung

Alcon is seeking a Sr. Director for the Quality Leadership Team to guide the total quality function across plants, ensuring compliance with QSRs, ISO 13485, MDR, and EU MDR while driving continuous improvement.

The role leads Quality Assurance, Regulatory Affairs, and related functions, overseeing budget and staffing, and ensuring robust quality systems. Onsite in Johns Creek, GA, with 5–10% travel and relocation support.

Qualifikationen

• Must be fluent in English (reading, writing, speaking) with strong communication skills.

Aufgaben

• Direct and manage Quality Assurance Departments, including Quality Systems, Documentation Control, Quality Control, Quality Engineering, Regulatory Affairs, Complaint Handling, and Laboratory Services.
• Ensure compliance with EU MDR 2017/745, MDCG 2019-07, and EU Council Directive 93/42/EEC (MDD).
• Provide direction on quality systems and tools to support process improvements.
• Act as Facility Management Representative to ensure effective Quality System implementation.
• Maintain compliance with FDA QSRs, ISO 13485, MDD/MDR, and ISO 14000 standards.
• Report on quality system performance and improvement needs.
• Promote awareness of regulatory and customer requirements across the organization.
• Implement systems to prevent recalls and manage post-market surveillance.

Kenntnisse

English fluency

Ausbildung

Bachelor's Degree

Jobbeschreibung

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. 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
• Where applicable, ensure compliance with European Union Medical Device Regulation (EU MDR) 2017/745 and meet experience requirements per Medical Device Coordination Group (MDCG) 2019-07 and EU Council Directive 93/42/EEC (MDD)
• Provide direction on quality systems and tools, focusing on process improvements
• Perform duties as Facility Management Representative to ensure effective Quality System implementation
• As applicable, 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 post market surveillance actions
• Maintain responsibility for product sterility systems and product release
• Support product registration requirements as applicable
• 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 target
• 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, (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training

What You'll Bring to Alcon

• Bachelor's Degree
• The ability to fluently read, write, understand and communicate in English
• 12 Years of Relevant Experience
• 8 Years of Demonstrated Leadership
• Travel: 5-10%
• Work Location: Onsite – Johns Creek, GA
• Relocation Assistance: Yes
• Sponsorship Assistance: None

Preferred Qualifications/Skills/Experience

If Designated as Responsible Person - For a pharmaceutical/aseptic plant/product, a pharmacy degree or other science-based qualifications are acceptable with 1-2 years’ experience of distribution activities. If designated PRRC - University degree in law, medicine, pharmacy, engineering or another relevant scientific discipline plus 1 year experience in device regulatory or QMS or 4 years of regulatory affairs or quality management experience related to medical devices. Degrees acquired outside the EU will need to be recognized by an EU Member State as equivalent to the EU corresponding qualification. Professional experience in regulatory affairs or in quality management systems relating to medical devices should be related to the EU requirements in the field and be substantive and recent.

How you can thrive at Alcon

Work together with colleagues to share standard methodologies and discoveries as work progresses. Discover your career in a fresh way through specific growth and development possibilities. Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!

Alcon provides a robust benefits package including health, life, retirement, flexible time off for exempt associates, PTO for hourly associates, and much more!

ALCON IS AN EQUAL OPPORTUNITY EMPLOYER AND PARTICIPATES IN E-VERIFY Alcon takes pride in maintaining an inclusive environment that values different perspectives and our policies are non-discriminatory in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, 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 [e-mail] and let us know the nature of your request and your contact information.

At Alcon, we are committed to helping people see better. We believe patients should have access to quality eye care regardless of their economic circumstances; however, barriers to good eye health exist for patients in both developed and emerging markets. Alcon develops and manufactures innovative devices to serve the full life cycle of eye care needs. Its surgical group is one of the largest makers of equipment used for cataract removal and laser vision correction. Its consumer products include the well-known Opti-Free line of contact lens solutions and related products. Alcon, which was founded in 1945, sells its products in 180 countries worldwide.