Ron M. Chai Email and Phone Number

AbbVie’s identity is shaped by the work we do - producing innovative medicines, continually investing in our pipeline, and giving back to create healthier, more vibrant communities. Most of all, this identity has been shaped by the beliefs we share that have emerged organically since AbbVie began.Abbvie's mission is to Create an innovation-driven, patient-focused specialty biopharmaceutical company capable of achieving sustainable top-tier performance through outstanding execution and a consistent stream of innovative new medicines.Overall responsible for Supplier Quality Management. Primary contact with suppliers on all quality related issues during both the supplier maintenance and supplier selection process. Responsible for overseeing supplier quality management activities and continuous improvement initiatives with suppliers. Qualify suppliers according to company requirements. Monitors parts from acquisition through inspection. • Manage and maintain the ZELTIQ supplier quality management program.• Maintain Approved Vendor List (ASL) and Supplier Files• Develop and prioritize an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure GMP's, ISO 13485, and company’s quality standards are met. • Lead Supplier audits and ensure suppliers implement and maintain any resulting corrective actions.• Responsible for driving continual process improvements with suppliers through Supplier Corrective Action Requests. • Evaluate and recommend improvements in receiving and in-process inspection methods, equipment, and sampling plans.• Establishes and maintains supplier quality metrics, scorecards, and trending. • Maintains compliance of Supplier Quality Management system to internal procedures, standards and regulations.

Fresenius is a global health care company with products and services for dialysis, the hospital and the medical care of patients at home.The Fresenius Group consists of four business segments, each of which is responsible for its own business operations worldwide: Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed.Around the world, Fresenius has about 170,000 employees, the majority in the United States.Fresenius Medical Care is the world's leading provider of products and services for patients with chronic kidney failure. With a network of 3,225 dialysis clinics in North America, Europe, Latin America, Asia-Pacific and Africa, Fresenius Medical Care treats 265,824 dialysis patients around the world (as of September 30, 2013).

Thoratec has been committed to developing advanced medical technologies to improve patient survival and quality of life. Thoratec provides the broadest mechanical circulatory support portfolio to treat the full range of clinical needs. Works together with Purchasing & Engineering to select and approve suppliers. Ensures supplier audits are conducted on a scheduled basis. Prepares audit reports based on audit findings. Follows up on corrective actions related to audit findings, nonconforming product, or overall supplier performance to ensure effective resolution and timely closure. Maintains master files of supplier audits and correspondence with suppliers per record retention requirements. Works with Purchasing to track ongoing supplier quality performance and work with suppliers on quality issues. Participates in activities required to qualify suppliers and maintain for various levels of approval, such as preferred, dock to stock, and certified suppliers. Interfaces with receiving inspection personnel. Works with Purchasing, Engineering, Manufacturing and Quality Assurance on supplier issues to assure timely acceptance of purchased product.

Provide technical support and leadership to build and sustain a best-in-class Quality System which meets the full requirements of ISO9001:2000, ISO-13485 quality standards and FDA 21CFR820 • Drive product quality and reliability with special focus in materials and supplier management - develop and support processes to meet quality objectives.• Manage supplier initial qualification & surveillance audit program.• Manage supplier quality performance monitoring process including but not limited to Product Quality, On Time Delivery and Customer Support.• Manage the supplier product RTV process including incoming and post production supplier product warranty/service.• Manage the Supplier Corrective Action/Preventive Action (typically referenced as SCAR) program.• Supporting member of the Quality Team – provide specific guidance and direction to general staff as well as department managers in implementation of the quality system and compliance with quality standards • Support internal auditing system to ensure full compliance to ISO and FDA quality regulations and requirements• Drive 6-Sigma and Best Practices – develop, implement and document procedures to sustain • Champion and support the LOR process to help recruit, retain and develop organizational talent• Provide cross functional support to other Quality Department functions.