Director, R&D Quality Assurance
Alcon
Summary
As Director, R&D Quality Assurance, you will play a critical leadership role in advancing quality assurance governance to ensure discipline, compliant, and value-driven quality decisions across the enterprise. 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 in partnership with senior leadership.
Job description
You will collaborate closely with R&D, Regulatory Affairs, Operations, and Franchise teams to strengthen quality execution, enhance monitoring capabilities, and translate complex quality and compliance dynamics into clear, actionable insights. Operating within established quality frameworks, you will provide forward-looking, data-driven recommendations that balance risk management, regulatory compliance, and competitive positioning.
The Director, Research & Development Quality Assurance (Professional Path), is primarily responsible for leading quality assurance for surgical ophthalmic devices, aligning with Research and Development Quality Assurance and Surgical Research and Development goals. You will guide the implementation of quality systems for new products, post-market improvements, and lifecycle management, ensuring design control and risk management processes are successfully executed.
In this role, a typical day will include:
- 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.
What You’ll Bring to Alcon:
- 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 Skills & Experience:
- 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
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
- 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
- Health insurance
- Life insurance
- Retirement planning
- Flexible time off
Company overview
Alcon Inc. is the global leader in eye care, dedicated to helping people see brilliantly. Founded in 1945 as a small pharmacy in Fort Worth, Texas, the company has grown into the world's largest eye care device company with complementary businesses in Surgical and Vision Care. As a Swiss-American multinational corporation headquartered in Geneva, Switzerland with major operations in Fort Worth, Texas, Alcon operates in 60 countries and serves patients in over 140 countries. The company's Surgical segment focuses on ophthalmic products for cataract surgery, vitreoretinal surgery, refractive laser surgery, and glaucoma surgery, including implantables, consumables, and surgical equipment. The Vision Care segment comprises daily disposable, reusable, and color-enhancing contact lenses, along with a comprehensive portfolio of ocular health products for dry eye, contact lens care, and ocular allergies. With over 75 years of heritage, Alcon has a long history of industry firsts and makes substantial annual investments in research and development to meet evolving customer needs and advance patient care. The company became an independent publicly-traded entity in 2019 after spinning off from Novartis.