Director, R&D Quality Assurance

Alcon Research•Lake Forest, CA

1d•$162,000 - $270,000

About The Position

At Alcon, we’re passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers. Are you ready to join us? We foster an inclusive culture and are looking for diverse, talented people to join Alcon. 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. 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. Success in this role requires strong strategic judgment, a deep understanding of quality assurance methodologies, and the ability to influence decision-making across a global, matrixed organization. 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.

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
Strong leadership, strategic thinking, and business acumen.
Data-driven decision-making with a keen eye for insights and trends.

Nice To Haves

Experience in healthcare, medical device, pharma, or a related field.
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

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.