Kimberly Truett

Kim has been in quality systems within the manufacturing industry for 30 years. She has spent 15 years focused on medical devices specifically in Class III implantable textiles such as aortic graphs, hernia mesh, heart valve materials, and Class IIa and IIb dental implants and abutments.

Kim joined NAMSA as a Senior Quality Systems Consultant in November 2024. She most recently worked as a Quality Consultant where she established a Quality Management System for a Class II medical device start up and served as Quality Manager and Management Representative for a Class II medical device company. Prior to consulting she worked for Zimmer Biomet in their dental division as a Quality and Compliance Project Manager with responsibility for managing the European Union’s Medical Device Regulation transition project, managing the internal audit program, establishing a Quality Management System at subsidiaries and integrating the Zimmer Quality Management System into the Biomet system after the merger. Additional responsibilities include managing CAPAs, Management Review, external standards, and leading the backroom during Notified Body and Regulatory audits.

Ms. Truett earned her Bachelor of Science in Business Administration from the University of South Carolina. She holds an Exemplar Global ISO 13485:2016 Lead Auditor Certification.

CORE COMPETENCIES

• Extensive experience establishing, maintaining, assessing, and improving Quality Management Systems
• Integrating Quality Management Systems for mergers and acquisitions
• Lead Auditor experience including internal, supplier, and third party
• Preparing for Notified Body and Regulatory audits including collecting all anticipated procedures and records requests, training potential auditees, and managing the back room
• Quality Management and Project Management
• Corrective and Preventive Action programs as a CAPA owner
  • Responsible for executing all Verification of Effectiveness actions for each CAPA
• Prepping materials and personnel for Management Review meetings
• Document control and record retention, process validations, product qualifications, master records, history records, FMEA/risk analysis, control plans, internal specifications, inspection/test instructions, sampling plans, product release and COAs, internal and supplier audits/audit plans, and complaints

RECENT PROJECTS

• Established QMS for new medical device company
• Served as Quality Assurance Manager and Management Representative for a medical device manufacturer
• Responsible for performing annual internal audits for large medical device manufacturer
• Performed CAPA remediation for a medical device manufacturer