Director, R&D Quality Assurance & Strategy

Alcon MX

Lake Forest (IL)

On-site

USD 184,000 - 238,000

Full time

14 days+
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Benefits offered by this job

Health benefits
Retirement plan
Flexible time off

Job summary

Alcon is seeking a Director, R&D Quality Assurance to lead governance across enterprise R&D programs, ensuring disciplined, compliant, and value-driven decisions. You will partner with R&D, Regulatory Affairs, Operations, and Franchise teams to strengthen quality execution and translate complex quality dynamics into actionable insights.

You will drive end-to-end quality systems for new products and lifecycle management, guiding design controls, risk management, and post-market

Qualifications

  • Bachelor’s Degree or equivalent in a related field.
  • Fluency in reading, writing, and speaking English.
  • 10 years of relevant experience in quality assurance for healthcare/medical devices.

Responsibilities

  • Lead strategic product development quality reviews and governance with R&D and Regulatory Affairs.
  • Adapt quality approaches for established products to improve performance across development programs.
  • Manage end-to-end Quality Governance processes and SLAs for timely quality requests and submissions.
  • Monitor governance performance and drive continuous improvements in workflows and documentation.
  • Conduct strategic quality reviews for R&D programs, assess risk, and align with global regulatory guidance.
  • Support enhanced quality monitoring through dashboards, reports, and insights.
  • Collaborate with global/regional teams to advance quality initiatives and ensure product integrity.

Skills

Leadership
Strategic thinking
Data-driven decisions
Quality governance
Regulatory knowledge

Education

Bachelor’s Degree

Tools

CPK/Ppk
SPC
FMEA (DFMEA/PFMEA)
ISO 14971
FDA Design Controls

Job description

Alcon is seeking a Director, R&D Quality Assurance to lead governance across enterprise R&D programs, ensuring disciplined, compliant, and value-driven decisions. You will partner with R&D, Regulatory Affairs, Operations, and Franchise teams to strengthen quality execution and translate complex quality dynamics into actionable insights.

You will drive end-to-end quality systems for new products and lifecycle management, guiding design controls, risk management, and post-market

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