Senior Director, Quality Leadership — Global QMS

Alcon; United States; On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Health insurance

Life insurance

Retirement plan

Flexible time off

Job summary

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.

Qualifications

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

Responsibilities

• 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.

Skills

English fluency

Education

Bachelor's Degree

Job description

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.