Interim Medical Device Quality Director - Sydney, Australia | Biospace
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Interim Medical Device Quality Director

Confidential Employer

Location:
Sydney, Australia
Posted Date:
9/6/2017
Position Type:
Contract
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Director, Medical Device, Quality,

Job Description


Our client in Sydney Australia is seeking an interim Quality Director to oversee the final stages of their medical device PMA submission, and to prepare the organization for an FDA pre-approval inspection. The device is an active implantable device that is currently in clinical trials in the US as well as Australia.  In this role, the interim Quality Director will oversee the commissioning of a manufacturing clean room located in Sydney, Australia.  Additional duties of this interim role includes:

-Responsibility for closing previously identified quality system compliance gaps
-Identifying and resolving additional areas of weakness within the organization’s Quality Management System
-Preparing the site and staff for an FDA Pre-approval inspection
-Coordinating additional quality management system audits as necessary
-Ensuring product and process controls have been fully established and implemented.

Requirements


10 years of Medical Device Quality experience with active implantable devices sold in the US is a must. Expertise with FDA Production and Process Controls, Design Controls, Management Controls, and CAPA is critical.  Software design and development as well as software risk management is a plus.

US consultant willing to re-locate for (1-6 month assignment) will be considered