Director, R&D Quality Assurance

Responsibilities

• Lead strategic product development quality reviews, including stage-gate and launch governance in partnership with R&D and Regulatory Affairs.
• Manage end-to-end Quality Governance processes and associated SLAs to ensure consistent handling of quality requests.
• Conduct strategic quality reviews for R&D programs, analyzing risk impact and providing recommendations aligned with global regulatory guidance.
• Collaborate with global and regional teams to advance quality initiatives that strengthen compliance and product integrity.
• Monitor governance performance and implement continuous improvements to workflows, documentation, and decision quality.
• Support enhanced quality monitoring capabilities through dashboards, reporting, and performance insights.

Requirements

• Bachelor’s Degree or equivalent years of directly related experience.
• 10 years of relevant professional experience.
• Ability to fluently read, write, understand, and communicate in English.

Preferred Qualifications

• Experience in healthcare, medical devices, or pharmaceuticals.
• Strong knowledge of 21 CFR Part 820, ISO 13485, and FDA Design Controls.
• Proficiency in ISO 14971 risk management and FMEA (DFMEA/PFMEA).
• Proficiency in process capability (CPK/Ppk) and statistical process control (SPC).
• Background in ophthalmic surgical instrumentation, console-based medical devices, or laser technology.

Benefits

• Focused growth and development opportunities.
• Robust benefits package including health, life, and retirement plans.
• Flexible time off.

About the Company

Alcon is a global leader in eye care, developing and manufacturing innovative devices to serve the full life cycle of eye care needs. From surgical equipment for cataract removal and laser vision correction to consumer contact lens solutions, Alcon is committed to helping people see brilliantly.