Mark Gee Email & Phone Number

Salt Lake City Metropolitan Area

Quality System implementation and right-sizing. Cut out the bureaucracy & non-value-added inefficiencies.

Sandy, Utah, United States

Cottonwood Heights, Utah

1. Management Representative for two Class II medical device manufacturing facilities.2. Lead team to achieved ISO 13485:2016 and MDSAP certification in 5 months at Utah facility. 3. Identified and closed FDA CFR 820 compliance gaps in UT and TN manufacturing facilities. 4. Implemented a CAPA program; resolved 64 non-concompliant CAPAs; trained personnel on root cause investigation techniques and effective CAPA completion. 5. Successfully hired, developed QA, QC and QE professionals at two sites. 6. Lead the cross functional team to establish CRB, MRB and an internal audit program. 7. Identified and resolved over 50 regulatory labeling gaps; IFU and Quick Start Guides into compliance and revision controlled. 8. Directed the initiative improving the document control efficiency by 80% by using LEAN principles.9. Implemented measurable Quality Objectives in manufacturing and through the QMS.10. Streamlined the customer complaint process and implemented complaints trending for the two facilities.

Charlotte, North Carolina

Managed the Quality Management System (QMS) for a $19B medical device manufacturer. My main focus was in four areas: 1) Managed the QMS and maintain regulatory compliance to the FDA's 21 CFR 820, 11, 803 and 1020, as well as, ISO 13485:2016, ISO 14971 and the European Medical Device Regulation 2017/745. 2) Manage the CAPA system and provide training for problem solving & root cause investigations, improving CAPA performance from 45% to 93%. 3) Manage the internal audit program and mentored the Internal Auditing Team, achieving MDSAP certification. 4) Managed the Customer Complaint Resolution system, achieving a 25% reduction of warranty complaints over one year.

Sandy, Utah

I directed the Intensive Out-Patient (IOP) services for individuals and their families affected by addiction and their sustained recovery. I was also a staff Therapist in a residential substance abuse/addiction recovery center. I utilized my education and business experience with healthy communication & core issue resolution skills to assist individuals and families through the addiction healing process and mend relationships.

South Jordan, Utah

I directed the product development and life-cycle of cutting-edge medical / dental products, including the regulatory registration and approvals of these devices domestically and internationally.1. Directed the Regulatory Affairs and Product Development teams of 15 professionals for a $20M world-class medical device manufacturer. This included all 510(k) approvals, as well as Technical File creation and maintenance. 2. Responsible to all FDA and ISO Design Control requirements for new product development and product changes. 3. Designated spokesperson when dealing with FDA, ISO Notified Bodies and international regulatory compliance auditors.4. Responsible for building quality into the product and maximizing the customer's experience.

Master'S Degree, Organizational Leadership, 3.9

My emphasis was on Systems Theory and how subsystem interrelate with each other to obtain synergy, which means "how the whole is greater.

Bachelor Of Science - Bs, Organizational Communication, General, 3.0

My emphasis was on Systems Theory and how subsystem interrelate with each other to obtain synergy, which means "how the whole is greater.