Supplier QA Analyst Job in Aliso Viejo 92651, California US
Supplier QA Analyst
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 9.4 billion in 2010. 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, RD and talent of Alcon, CIBA VISION and Novartis Ophthalmics. Today, Alcon has more than 22,000 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 Supplier Quality Engineer will be responsible for evaluating and monitoring suppliers to ensure regulatory compliance and organizational supplier performance goals are met.
Essential Duties and Responsibilities:
- Support all supplier related activities such as performance monitoring, creation and closure of supplier corrective actions (SCAR) and high level corrective action requests (CAPA).
- Perform lead auditor function in the execution and management of assessments of suppliers. Lead Supplier Quality and Process Assessments, help drive systemic improvements and support site initiatives.
- Maintain Database(s) that ensures all first article and qualification requirements have been met prior to material being released for production.
- Follow up on observations and recommendations with suppliers to resolve quality issues.
- May represent the Supplier Quality function in Material Review Board and ensure any supplier corrective actions have been implemented and verified for effectively.
- Participate and/or lead quality aspects of team initiatives to improve value and overall performance of our suppliers.
Qualification Requirements:
- Bachelor of Arts Degree in Engineering (Industrial, Mechanical or Electrical).
- Requires 2+ years experience in Quality Assurance with emphasis on Supplier Quality.
- Working knowledge in manufacturing of medical devices and regulatory requirements is preferred
- Experience in mechanical (including machining) components and assemblies preferred.
- Microsoft Word, Excel and PowerPoint. Experience with electronic documentation systems and ERP systems required.
Minimum Experience Requirements:
- 3 -5 years related industry experience
- Working knowledge of SPC, FMEA, and other quality improvement techniques is highly desired
- Must be knowledgeable of cGMP and relevant requirements
- Must have good knowledge of MS office tools to include excel and access
- Should be familiar with closed loop ERP systems.
- Excellent verbal and written communication skills
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.
