Director, R&D Quality Assurance

Director, R&D Quality Assurance – Alcon At Alcon, we’re passionate about enhancing sight and helping people see brilliantly. As a Director, R&D Quality Assurance, you will provide 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. 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. Qualifications Bachelor’s Degree or equivalent experience; 10+ years of relevant experience. Fluency in reading, writing, and communicating in English. Strong leadership, strategic thinking, and business acumen. Preferred Skills & Experience Experience in healthcare, medical device, pharma, or a related field. 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 other employee benefits. Compensation Pay Range: $183,600 – $237,600 per year. Equal Opportunity Employer 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. #J-18808-Ljbffr