Kathy Cunningham Email and Phone Number

Effective August 13, 2021, I have placed myself in semi-retirement. After 46 years of working full-time, I decided it was time to take a more relaxed approach to life. I'm very much enjoying the slower pace to my life and was surprised at how quickly I settled into my new life. I am blessed that I enjoyed the different positions I held throughout my working career. I'll see what comes next!!

Conduct supplier reassessments by soliciting updated supplier information and evaluating and analyzing submissions by suppliers to determine if there have been any significant changes which would indicate that an audit should be conducted. Manage input to maintain an updated ASL (Approved Supplier List). Review Supplier Quality Agreements to determine if they continue to meet our current needs and update as required. Support internal and external audits as required. Serve as mentor and trainer for new Global Supplier Assurance team members.

Facilitated the Supplier Control process at a small medical device manufacturing company by assisting in supplier qualifications and supplier auditing.

Responsibilities include planning and executing QMS and EMS internal audits at 40+ US and OUS sites. Comprehensive audit reports are written and distributed. Audit observations are managed and tracked through verification of effectiveness conducted at subsequent audits. Knowledge of regulations and standards include ISO 13485, ISO 14001, MDSAP, Canada, Japan, Austraila, China, Brazil and other geographies as applicable. Experienced in supporting FDA and Notified Body external audits and comfortable in running both front and back rooms.Support of Regulatory Affairs for registration and country specific license renewals.

Led supplier, purchasing and part master modules for SAP implementation at 2 sites Purchased a wide range of goods and services (metal, plastics, resins, injection molded components). Served as team leader for developing and implementation of an ACCESS Database to manage the Approved Supplier List and reworked supplier selection process. Partipated in NPI (new product introduction) teams. Led daily cross-functrional team meetings to determine schedule adherence. Generated supplier scorecards. Planned and executed supplier audits for existing and new suppliers.

Established the Purchasing department be authoring and implementing policies and procedures. Purchased all goods and services (Great Plains) required. Generated work orders and kitted material for manufacturing builds. Planned manufacturing and other special Engineering builds. Led schedule adherence meetings and adjusted build plans as needed. Developed and implemented a Supplier Quality Assessment program which included conducting audits at supplier facilities.