Jon Brockman Email & Phone Number

Plymouth Meeting, PA, US

Quality Consulting and QMS guidance

Poway, California, US

Laguna Hills, California/San Diego, US

Establishing and implementing the initial Quality System (compliant with ISO 13485:2016 and FDA’s 21 CFR 820) and writing of FDA Pre-Submissions for a new disruptive technology for an integrated Continuous Glucose Monitor (iCGM) wearable device. Reason for leaving – company experienced significant delays in developing functional product and had a reduction.

Vista, CA, US

Start-Up. Layoff due to loss of funding.

San Diego, California, US

Start-Up. Layoff due to loss of funding.

US

Directed, coordinated and dramatically improved the Regulatory Affairs and Quality System/Assurance activities for a Class II IVD Blood Gas Analyzer design and manufacturing facility. Managed successful FDA audit in 2014 with no 483 observations. Managed Quality Engineering, Quality Assurance, Quality Control, Document Control, and Regulatory Affairs..

Irvine, CA, US

Reviewed and improved the Quality System to comply with the FDA's QSR, and prepare for ISO 13485/CMDCAS/MDD certification, achieved in March of 2012. Recruit Quality staff to support the business relocation and growth. Support Design project to launch company's first product (achieved in November, 2011).

Implemented a Quality System compliant to the FDA’s Quality System Regulation. Developed, validated and implemented Master Control (Document Control and Training)

San Diego, CA, US

As the Head of Quality for the Americas, established and coordinated all aspects of the Quality System, >70% of a $1 Billion global business of Class II medical devices for the treatment of obstructive sleep apnea. Developed strategic plans, recruited and developed the Quality Assurance/Control, Quality Engineering, Document Control, and Regulatory Affairs.

Directed the Quality System on the design, manufacturing, and distribution on sterile implantable vascular grafts.

Developed and directed the Quality System within Class II Medical Devices (Bone Growth Stimulators and External Fixation Devices that were sterilized), design, manufacturing, distribution, and post surveillance.

Coordinated all aspects of the company’s Quality System and Test programs throughout the organization’s Diagnostic Ultrasound (510k) divisions, from start-up to $35mm in annual sales, establishing and administrating the program, coaching employees, and facilitating continuous improvement throughout the organization. Established strategic plans, policies.