As Director of Quality Systems at SBME, Ms. Bartz is responsible for the development and implementation of Quality Systems for biologics and medical device companies. She has extensive experience in all aspects of the Quality System. Ms. Bartz is an expert at designing innovative solutions for document control, supplier management, CAPA, and all other areas of the Quality Management System for your business. Cassie is also adept at project management and able to adhere to deadlines despite the inevitable challenges that arise.
Cassie conducts quality system audits under 21 CFR 820, ISO 13485, 21 CFR 1271, and American Association of Tissue Banking (AATB) regulations. Cassie has extensive experience as an internal auditor performing process and procedure audits. Prior to joining SBME, Cassie worked for 7 years in the biologics industry interfacing with numerous tissue recovery agencies. Her responsibilities included donor chart review, tissue processing record review, and training.
Cassie’s primary area of expertise lies within quality systems management. Cassie also provides project management support and works on various project teams to ensure compliance.
Quality System Management
- Full Quality System Management including: Document Control, Record Control, Quality Planning and Completion of Quality Objectives, Training, Labeling Review, Internal Audits, Supplier Management and Auditing, Corrective and Preventive Action, Complaint Investigation, Field Action (Recalls), and NCR Investigation and Resolution
- Drive Quality System performance and continual improvement through the establishment and ongoing evaluation of quality metrics.
- Manage projects to ensure quality compliance and adherence to desired timelines
- Participate in project teams to ensure the highest quality of work and most efficient development
- Heart Valves, Vascular Grafts, Bone Tissues, Electronic Medical Devices, Orthopedic devices, Synthetic dura mater implants
Industries / Products
Secure BioMed Evaluations
Director of Quality Systems, August 2016 – Present
Quality Manager, August 2013 – August 2016
- Implementation and management of Quality Systems for Medical Device and Biologics companies for compliance with 21 CFR 820, ISO 13485, EU Medical Device Directive, Canadian Medical Device Regulations, and AATB Standards
- Perform internal and supplier audits for medical device and / or biologic companies to ensure compliance with current regulations / standards
- Create and maintain supplier files, perform document control, and conduct management review meetings for multiple medical device / biologic companies
- Develop and deliver ISO, FDA, and AATB training
- Manage program for the competency assessment of coordinators conducting medical and social history questionnaires
- Participate in product design reviews and assist in the development of design history file documents
- Act as project manager for multiple clients
- Assist clients in the receipt, investigation, and closure of Complaints, CAPA, and NCRs
Donor Quality Assurance Specialist, July 2007 – August 2013
- Performs a quality review of tissue donor records to verify compliance with applicable internal, state, and FDA regulations.
- Review and recommend the final disposition of donor records.
- Aid management in the training of new employees on standards, procedures and specifications.
- Aid management in updating standard operating procedures for validity, functionality, and accuracy
Internal Quality Auditor, August 2009 – August 2013
- Perform process and procedure internal audits to ensure compliance and identify any possible non-conformances.
Donor Quality Assurance Analyst, July 2007 – July 2008
- Correspond with recovery partners to solicit information necessary to complete the donor record.
- Review and recommend the intermediate disposition of donor records.
Tissue Quality Assurance Associate, June 2006 – July 2007
- Review tissue processing records for compliance to applicable internal standards and government regulations.
- Perform Quality Control functions including review of batch records.
- Bachelor’s Degree, Biology, Berry College
- Certified Tissue Bank Specialist, AATB
- BSI Lead Auditor Training
7828 Hickory Flat Highway, Suite 120, Woodstock, GA 30188