Quality Engineer I, Compliance

Job description

Job Description

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 QA Engineer I in the Manufacturing Technical Operations division located in Irvine, CA. The primary scope of this role will be to develop, modify, apply and maintain quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place.

Responsibilities include but are not limited to:
• Provide technical support to Quality and the entire organization to assure medical devices are designed and manufactured with high quality and reliability, within all regulatory requirements and meet or exceed customer expectations. Assess Quality System for compliance to regulations, standards, and company requirements. Provides technical expertise to optimize the quality system
• Perform internal audits of quality system functions to the applicable regulations, standards, and company requirements
• Support external audits (notified body, regulatory agency inspections), by way of auditing, training, preparation, and tracking corrective actions
• Review of new regulatory standards / guidelines and determination of impact of changes on Alcon systems and procedures
• Lead process improvement CAPA projects with minimal supervision, working with cross-functional teams to timely and effective closures
• Draft and submit responses to global regulatory inquiries related to reportable complaints
• Assist in various Compliance activities (e.g. Field Actions, Management Reviews, Metrics)

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.

Desired profile

Minimum requirements

Minimum Qualifications:
• Bachelor of Arts Degree in Regulatory Sciences or Engineering (Biomedical, Industrial, Mechanical or Electrical) or equivalent industry experience. Masters in Regulatory Sciences or Biomedical Engineering preferred
• 1-3 years of Medical Device industry experience preferred
• Experienced in auditing to 21 CFR 820, ISO 13485, MDD requirements
• No prior experience required

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.