Consultants

president and CEO

Linda Lovett

Linda Lovett is the President and CEO of Lovett Consulting, LLC, and brings over 26 years of experience in strategic and tactical quality assurance leadership for the Medical Device Industry.

A results oriented leader, Linda is focused on early stage, rapid growth and regulatory compliance environments. She has a proven track record of performance in growth and highly regulated organizations, including:

• Successful regulatory compliance remediation activities for clients addressing external audit 483 observations, notified body nonconformities and field actions.

• Quality Assurance direction to assure compliance to (CDRH) Quality System Regulations, MDD, ISO 13485:2003 and ISO 13485:2016, ISO 14971, and CMDR for Class I (Sterile); Class II, and Class III (PMA) products and 21 CFR Part 11. 

• Medical Devices: orthopedic, orthopedic implants, spinal, vascular (cardiology, neurovascular), electromechanical. 

• In Vitro Diagnostics: electromechanical analyzers, controls and reagents (hematology, FOB, transplant, tissue characterization).

In addition, Linda is an expert on Global Quality Strategy Development/ Strategic Initiatives/ Compliance remediation, Executive Management/ Business Reviews, Compliance Audits, QA metric development and integration, Implement Electronic QMS, Budget planning and cost management.

Linda is a sought-after industry speaker and presenter on quality topics including Supplier Management, Risk Management and Corrective and Preventive Action systems at industry conferences.

Linda has a Bachelor of Science degree in Zoology from Michigan State University with emphasis in Mathematics and Chemistry. She has worked for companies such as Abbott Laboratories, Kyphon, Inc. acquired by Medtronic in 2007 and currently is consulting with multiple medical device companies. Linda lives in San Ramon, CA, with her husband and four children.

Education

MICHIGAN STATE UNIVERSITY

BS in Zoology (Chemistry, Biology, Mathematics), 1985

Affiliations

• Orthopedic Design & Technology Magazine (ODTM), Editorial Advisory Board Member

Quality Engineering Associate

Kathy Dzieciolowski

Kathy Dzieciolowski (phonetic pronunciation is “Gin-cha-woof-ski” or just D-13) is a quality engineering associate with an eye for detail.

She enjoys working in the medical device industry and specializes in the following areas:


• Evaluate and ensure compliance of the client’s quality system and records with US and OUS regulatory requirements 

• Assist in the development and implementation of the client’s quality management system

• Development and maintenance of design control documentation to support the client’s product design history file (DHF)    

• Author design control documentation for verification, validation, master plans, and other required documentation supporting regulatory submissions and design control activities

• Review quality records for compliance to procedures, protocols, regulations and standards

• Assist in the promotion, maintenance and supporting compliance to applicable federal and state regulations, international standards, and the client’s Quality Policy as required

Kathy has a BSE in Industrial and Operations Engineering from the University of Michigan.  Earlier in her career she worked for General Electric (GE) as a sales engineer. She also worked at Abbott, and the Center for Ergonomics Laboratory at the University of Michigan. She has knowledge of six-sigma and project management, and is expeditious in getting tasks done. 

She enjoys staying active and healthy. She was on the Varsity Rowing Team in college and competes in triathlons. She has completed a half Ironman triathlon, but prefers the sprint or Olympic distances. Kathy currently lives in Michigan with her husband and three young boys.