Auditor - Medical Devices Branch

• Jan 2021 - Present

Quality Engineer

• Aug 2017 - Jan 2021

I support the ICU Medical ANZ business to achieve strategic commercial goals via actively maintaining key areas of the QMS and ensuring all regulatory requirements are met. My team have successfully integrated three organizations (ICU Medical, Hospira & Medical Australia), transitioned the QMS to ISO 13485:2016, conducted a site move and navigated through regulatory audits with minimal impact to commercial activities. My role requires me to work with cross functional teams across the globe to create value through process excellence and continual improvement efforts. I am actively involved with Operations & Service Quality and provide guidance on compliance and strategic objectives. Key Roles: ♦ Lead Quality Auditor - International Supplier / TPM / Internal ♦ Create, review, and approve Risk Assessments (FMEA, CAPA, etc.) ♦ Analyze process and product non-conformance failure investigations and implement comprehensive corrective and preventive action plans ♦ Liaise with global cross functional teams to meet mutual outcomes ♦ Ensure compliance to TGA, EU & FDA regulations ♦ Track and trend Quality Indicators & Metrics ♦ Strategic Quality Planning for the business ♦ Assistance in sterilization validation activities ♦ Assistance in regulatory compliance projects/initiatives for US, Australia, and the European Union Show less

Quality Engineer

• Feb 2016 - Jul 2017

Trainee Engineer

• Jun 2015 - Aug 2015

Biomedial Engineering Intern

• Dec 2014 - Feb 2015