Melita Ball

Current

• Owner/Principal Consultant at MBC & Associates (Sole Proprietorship)

Past

• Director, Quality Assurance at Third Wave Technologies
• Manager, Regulatory Compliance at Ventana Medical Systems
• Sr. Manager, Corp. Quality System Training & Documentation at ALARIS Medical Systems

2 more...

Education

• The George Washington University
• Bridgewater College

Recommended

3 people have recommended Melita

Connections

106 connections

Industry

Biotechnology

Websites

• My Company

Melita Ball ’s Summary

Ms. Ball is a Medical Device and Biotechnology professional with over 17 years of experience in all aspects of Quality Assurance and Regulatory Compliance. She possesses particular expertise in performing regulatory compliance audits to 21 CFR Parts 820, 803, & 11, establishing business focused quality systems, and developing curriculum for quality system training programs. Ms. Ball is a Certified Quality Auditor (CQA) with extensive demonstrated experience auditing to FDA regulations and ISO 13485 within the Medical Device and Biotechnology industries.

Melita Ball ’s Specialties:

Project Management
Regulatory Compliance
Quality Systems
Quality Assurance
Automation of Business Processes
Document Control & Configuration Management
Quality System & Regulatory Assessments & Audits
Customized Training programs
Regulatory strategies & submissions
Design Control Process assistance
CAPA Programs
Complaint Management & Reporting
Recall Management
Nonconforming Material programs & management
Business Software Validation
Lean Manufacturing

Additional Information

Melita Ball ’s Websites:

• My Company