Scott Evans Email & Phone Number

Lexington, Massachusetts, United States

Barrington, Illinois

Greater Chicago Area

Barrington, IL

Barrington, IL

Kenosha, WI

Reporting to the President of Bradshaw Medical, Inc. Responsible for Bradshaw’s ISO 13485 certified quality system including training, CAPAs, customer complaints and document archives as well as quality engineering and manufacturing quality. Ownership of the quality and regulatory organization includes management of 19 direct reports.

Round Lake, IL

Reporting to the Director of Quality for New Product Development. Responsible for overseeing all infusion pump product development projects for Baxter Healthcare including management of Quality Engineering direct reports. Provides program oversight to a product line obtained in a corporate acquisition, distribution of another pump into new markets, as well.

Round Lake, IL

Reported to the Sr. Director of Quality for New Product Development. Quality leader embedded with an infusion pump product development team. Represented the quality function in program core team and steering committee meetings. Responsible for all aspects of quality related to the development of updates to the device including device design control.

Round Lake, IL

Managed the quality system integration of a company acquired by Baxter Healthcare. Was the quality leader and core team member of a new product development team designing an infusion pump. Oversaw the operations of a remote engineering team located in Irvine, California.

Round Lake, IL

Acted as the quality leader for several infusion pump post-market support teams. Performed install-base complaint trending and analysis and presented for management consumption. Managed CAPA metrics and trending for senior management as well as quality consulting to CAPA owners and investigators. Provided audit support for FDA and third-party audit.

Barrington, IL

Owned the risk management files for all new products developed by GE Healthcare Information Technologies. Defined new product development requirements related to safety (risk management) and global standards and regulations. Provided regulatory and risk management consulting within the engineering organization.

Barrington, IL

Was team lead for all global PACS Customer Loyalty Leaders; including direct supervision of subordinates. Owned the Customer Satisfaction Opportunity (CSO) process for all PACS customers in North America, Central America and South America. Interfaced directly with upset and angry customers and assisted in issue identification, resolution and deployment to.

Mount Prospect, IL

Owned the global product complaint process for the GE Healthcare Information Technologies business including tracking and trending of all global customer complaints and filing of Medical Device Reports (MDRs). Represented the Information Technologies division in the definition and creation of a new complaint handling system and accompanying operating.

Mount Prospect, IL

Ensured that all GE products from the Imaging and Information Systems business were globally approved for distribution. This included authoring global regulatory submissions including FDA 510(k)s (K023557 and K020483), Canadian, Korean, Chinese, and Japanese submissions as well as managing global product recalls (Class 2 product recall Z-0857-1/Z-0858-1)..

Elmhurst, IL

Provided life saving procedures and transportation in an emergency setting for approximately 6000 patients. Worked directly with patients and family members while they were under extreme stress. Duties also included training new paramedics as well as teaching Emergency Medical Technician (EMT) and CPR classes.

Provided clinical patient care in an Emergency Department.

M.S., Healthcare Technologies Management

B.S., Bioengineeering