Anna Mueller Email & Phone Number

Hood River, Oregon, United States

Bingen, Wa

Vancouver, Washington

QMS experience: ISO 9001:2015; ISO 13485:2016; AS9100D; regulatory compliance to FDA medical device 21CFR 820. Supplier management, CAPA / Root cause analysis, certified lead AS9100D auditor, lean manufacturing, customer feedback & communication. My goal: compliance through teamwork and mutual understanding of requirements.

Supplier management: qualification and monitoring. Supplier auditing. Nonconforming product process management. Raw material specifications. Internal auditing. ISO 13485:2003; FDA 21CFR 820.

Supplier Quality activities: audits, CAPA, specification development, supplier quality agreementsPerforms internal and supplier audits to ISO 13485, ISO 9001, 21CFR 820, Canadian SOR, EU MDD.CAPA, Customer Complaints, Analysis of DataTrainingEnvironmental Monitoring

Assisted in implementing a CGMP quality system for company historically focused on research processes: microbiology testing; environmental monitoring, validation, document control, internal audits, database development, equipment management, cleanroom

CAPA, internal audits, blood services associated quality procedures

Document control, CAPA, Product Release, internal auditing

Microbiology, Manufacturing, Document Control, GMP Training

Quality Control Microbiology