Director, R&D Quality Assurance

About the role

The Director, R&D Quality Assurance leads quality assurance for surgical ophthalmic devices, aligning with Research and Development Quality Assurance and Surgical Research and Development goals. This role has end-to-end ownership of quality governance across R&D programs, leading strategic quality reviews for product development, regulatory submissions, and portfolio initiatives.

Responsibilities

• Lead strategic product development quality reviews, including stage-gate and launch governance inputs in partnership with R&D and Regulatory Affairs.
• Adapt quality and compliance approaches for established products to optimize performance across targeted development programs and market segments.
• Manage the end-to-end Quality Governance process and associated SLAs, ensuring timely and consistent handling of quality requests and submissions.
• Monitor governance performance and implement continuous improvements to workflows, documentation, and decision quality.
• Conduct strategic quality reviews for R&D programs, analyzing risk impact and developing quality recommendations aligned with global regulatory guidance.
• Support enhanced quality monitoring capabilities through dashboards, reporting, and performance insights.
• Collaborate with global and regional teams to advance quality initiatives that strengthen compliance and product integrity.
• Apply strategic thinking, industry expertise, quality management technologies and optimization tools to enhance quality effectiveness.
• Demonstrate strong leadership and influence in driving quality initiatives and representing Quality Assurance across Regulatory, R&D, and related forums.

Requirements

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +18 yrs; Assoc.+14 yrs; M.S.+7 yrs; PhD+6 yrs)
• The ability to fluently read, write, understand, and communicate in English
• 10 Years of Relevant Experience Preferred
• Experience in healthcare, medical device, pharma, or a related field
• Strong leadership, strategic thinking, and business acumen
• Data-driven decision-making with a keen eye for insights and trends
• Proficiency in process capability (CPK/Ppk) and statistical process control (SPC) for critical component qualification within medical device manufacturing
• Strong knowledge of FMEA (DFMEA/PFMEA) and ISO 14971 risk management as applied to medical devices
• Working knowledge of 21 CFR Part 820, ISO 13485, and FDA Design Controls
• Background in ophthalmic surgical instrumentation or console-based medical devices strongly preferred
• Laser technology experience a plus

Qualifications

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +18 yrs; Assoc.+14 yrs; M.S.+7 yrs; PhD+6 yrs)

Skills

• The ability to fluently read, write, understand, and communicate in English
• 10 Years of Relevant Experience Preferred
• Experience in healthcare, medical device, pharma, or a related field
• Strong leadership, strategic thinking, and business acumen
• Data-driven decision-making with a keen eye for insights and trends
• Proficiency in process capability (CPK/Ppk) and statistical process control (SPC) for critical component qualification within medical device manufacturing
• Strong knowledge of FMEA (DFMEA/PFMEA) and ISO 14971 risk management as applied to medical devices
• Working knowledge of 21 CFR Part 820, ISO 13485, and FDA Design Controls
• Background in ophthalmic surgical instrumentation or console-based medical devices strongly preferred
• Laser technology experience a plus

Benefits

Alcon provides a robust benefits package including health, life, retirement, flexible time off, and much more!

Pay

Pay Range 183,600.00 - 237,600.00

Schedule

Annual