Director, R&D Quality Assurance

alcon; Lake Forest (CA); On-site; USD 183,600 - 237,600; Full time

Benefits offered by this job

Focused growth and development opportunities

Robust benefits package including health and retirement

Flexible time off

Job summary

Alcon is seeking a Director of R&D Quality Assurance to lead quality governance for surgical ophthalmic devices. The role involves strategic quality reviews, regulatory compliance, and collaboration across R&D, Regulatory Affairs, and Operations.

Applicants should have a Bachelor's degree or equivalent experience and at least 10 years in relevant fields. This position offers opportunities for impactful leadership within a dynamic organization dedicated to improving lives through innovative products.

Qualifications

• 10 years of relevant experience in healthcare, medical devices, or pharma.
• Ability to fluently read, write, and speak in English.
• Experience in risk management methodologies.

Responsibilities

• Lead strategic product development quality reviews.
• Monitor governance performance and implement improvements.
• Collaborate with global teams to advance quality initiatives.

Skills

Strategic thinking

Leadership

Data-driven decision-making

Quality management technologies

Education

Bachelor's Degree or Equivalent experience

Tools

Statistical Process Control (SPC)

ISO 13485

21 CFR Part 820

Job description

About the Role

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, compliance, 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.

Typical Day

• 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

Benefits

• See your career like never before with focused growth and development opportunities
• Join Alcon's mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!
• Alcon provides a robust benefits package including health, life, retirement, flexible time off, and much more!

Compensation

Pay Range: 183,600.00 - 237,600.00

Pay Frequency: Annual

Equal Employment Opportunity

Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to [e-mail] and let us know the nature of your request and your contact information.