Manager, Quality Operations, R&D Quality Assurance

Alcon MX; Lake Forest (IL); On-site; USD 122,000 - 157,000; Full time

Job summary

Alcon is seeking a Manager, Research & Development Quality Assurance to design, deploy, and monitor Quality Systems within the Instrumentation R&D group at our Lake Forest, CA facility. You will lead training, change control, CAPAs and audits to ensure regulatory compliance and robust documentation.

The role requires a Bachelor's degree or equivalent plus around 5 years of relevant experience, with English fluency, and onsite work hours Mon–Fri 8:00 AM–5:00 PM CST.

Qualifications

• Bachelor’s degree or equivalent years of directly related experience.
• Fluent English reading, writing, understanding and communicating effectively.

Responsibilities

• Design, deploy, and monitor Quality Systems within Alcon Instrumentation R&D.
• Handle training, change control, non-conformances, investigations, CAPAs, supplier management, audits, and document control.
• Ensure compliance with GxP and SOPs, maintain rigorous documentation.
• Commit to continuous improvement and regulatory compliance across R&D activities.

Skills

English language

Education

Bachelor’s Degree or equivalent

Job description

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? This role is part of Alcon's Quality & Regulatory Affairs function, a team that ensures our products are in compliance with global, local, and internal regulations and meet the strictest standards of quality as we help people see brilliantly.

The Manager, Research & Development Quality Assurance is primarily responsible for designing, deploying, and monitoring Quality Systems within Alcon Instrumentation R&D. You will handle training, change control, non-conformances, investigations, Corrective and Preventive Actions (CAPAs), supplier management, audits, document control, and compliance at our Facility in Lake Forest, CA.

Specifics Include

• Manage individual projects, applying advanced knowledge to achieve objectives and enhance project performance and operational efficiency.
• Develop and implement quality assurance strategies, ensuring compliance with industry standards and drive continuous improvement.
• Make operational decisions for projects, managing resources and timelines.
• Assure accurate and appropriate supporting documentation according to a defined design plan.
• Identify and contribute to revisions of Standard Operating Procedures.
• Ensure compliance of all Research and Development (R&D) activities within product development and direct R&D personnel to execute appropriately.
• Adhere to Good Practice (GxP) regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training.
• Commit to compliance with regulatory requirements and continuous improvement in operations.
• Associates are responsible for meeting their individual job requirements and contributing to the overall compliance of the organization.
• Compliance with regulatory requirements and a commitment to continuous improvement are essential to our operations.

Individual Contributor

What you’ll bring to Alcon

Bachelor’s Degree or equivalent years of directly related experience (or high school +13 yrs; Assoc.+9 yrs; M.S.+2 yrs; PhD+0 yrs)

The ability to fluently read, write, understand and communicate in English

5 Years of Relevant Experience

Work Hours

Work Hours: Monday – Friday, 8:00 AM – 5:00 PM CST

Location

Onsite

Travel Requirements

Up to 10%

Relocation Assistance

None

Sponsorship Available

No

Preferred

Medical Device or other regulated industry

How you can thrive at Alcon

Collaborate with teammates to share standard processes and learnings as work evolves! Join Alcon’s mission to provide top-tier, innovative products and solutions to enhance sight & enhance lives. Grow your career in a highly collaborative and diverse environment.

Alcon provides robust benefits package including health, life, retirement, flexible time off for salaried associates, paid time off for hourly associates and much more!

Pay Range

121,550.00 - 157,300.00 Pay Frequency Annual

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.

At Alcon, we are committed to helping people see better. We believe patients should have access to quality eye care regardless of their economic circumstances; however, barriers to good eye health exist for patients in both developed and emerging markets. Alcon develops and manufactures innovative devices to serve the full life cycle of eye care needs. Its surgical group is one of the largest makers of equipment used for cataract removal and laser vision correction. Its consumer products include the well‑known Opti‑Free line of contact lens solutions and related products. Alcon, which was founded in 1945, sells its products in 180 countries worldwide.