Quality Analyst III
Building on its heritage of more than 65 years, Alcon, the global leader in eye care, is the second largest division of the Novartis Group with combined pro-forma sales of more than USD 10 billion in 2013. The division was formed by Novartis on April 8, 2011, following the closing of the merger between Alcon and Novartis. The new Alcon Division combines the product portfolios, commercialization capabilities, R&D and talent of Alcon, CIBA VISION and Novartis Ophthalmics. Today, Alcon has more than 25,000 employees with headquarters in Fort Worth, Texas, U.S.A. Alcon's three businesses - Surgical, Pharmaceutical and Vision Care - meet the diverse needs of eye care professionals and patients offering the widest spectrum of eye care products with operations in 75 countries and products available in 180 markets. For more information, visit www.alcon.com.
The Manufacturing Technical Operations division residing in Irvine, CA and Lake Forest, CA specializes in Surgical Instrumentation. Alcon offers the industry's most complete line of ophthalmic surgical products, enabling surgeons to achieve the best results for their patients. Our surgical portfolio includes technologies and devices for cataract, retinal, glaucoma and refractive surgery, as well as advanced technology intraocular lenses (ATIOLs) to treat cataracts and refractive errors, like presbyopia and astigmatism. We also provide advanced viscoelastics, surgical solutions, surgical packs, and other disposable products for cataract and vitreoretinal surgery.
Alcon is currently seeking a Quality Analyst III in the Manufacturing Technical Operations division located in Irvine, CA. The primary scope of this role will be to maintain Quality Systems to meet medical device standards and regulatory requirements. Provide training for Quality Systems.
Responsibilities include but are not limited to:
- Ownership of Internal Audits, Management Review, Site Metrics and associated programs
- Assist in management of Non-Conformance/CAPA, Training, and Trending activities
- Manage Quality System and Key Performance Indicator reporting metrics
- Manage Management Review and Quality Council activities (including but not limited to agendas, meeting facilitation, minutes, action item tracking)
- Ensure required timelines are met
- Maintain knowledge of ISO standards and guidelines as they relate to quality systems and apply appropriate implementation strategies
- Participate in external (Health Authority, Notified Body) and internal audits as required
- Support in monitoring any open actions and required responses
- Work with Alcon Global Quality System communities to support initiatives
- Create an environment that ensures ongoing compliance while encouraging innovation
- Lead and support implementation of system improvements
- Participate in compliance activities that relate to the department and the company as a whole
- Write/revise/provide training for area SOPs
- Develop and execute training for area Quality Systems as required
- Mentor and develop colleagues EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Minimum requirements Minimum Qualifications:
- B.S. in Science or Engineering
- 3 years of experience in a manufacturing engineering environment with a compliance and/or quality function
No relocation package is allocated for this position.
Our generous benefits package includes the Novartis Investment Savings 401(k) Plan which provides a company contribution of up to 6%. In addition, after one year of service, employees are eligible for the Alcon Retirement Plan (ARP), to which Alcon contributes 6% of eligible pay. By combining the Company's contributions to the 401(k) and ARP, employees can receive up to 12% of eligible pay from Alcon towards retirement. Alcon also offers a premier level of coverage for medical, dental, vision, life and disability coverage, an on-site fitness center and much more. Consider having all this in a fast paced environment within a stable world-class organization.
Meet Some of Alcon's Employees
Director, Regional Sales
Kristen oversees the entire 50-person Regional Sales Team for Alcon’s cataracts business in America. She helps handle products and services associated with the surgical side of operations.
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