For Australia Europe and the USA.........
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Job 1 of 1Listed 03 Dec 2007
Work Type: Full Time Sub-Classification: Quality Assurance
Area: Sydney - North Advertiser: Private Advertiser
Quality Assurance Director
International Medical Device Company.
Australian publicly listed company.
Chatswood location.
Ventracor is an international medical device company, headquartered in Sydney, that manufactures the VentrAssistâ„¢ Left Ventricular Assist Device (LVAD), an implantable blood pump designed as long term therapy for people in end stage heart failure.
We are looking for an experienced QA Director to manage, coordinate and monitor the global quality management system and related functions in Ventracor, an Australian publicly listed company (ASX:VCR).
Key Challenges:
Manage and monitor the company quality assurance program to demonstrate compliance with Australian, European and American regulatory requirements for active implantable medical devices;
Promote quality performance improvement throughout the organization;
To manage and coordinate the team responsible for QA and QC to deliver company quality assurance requirements and outcomes;
Act as a mentor and provide coaching and training in regulations for company personnel;
In particular, he/she will work closely with engineering, marketing, manufacturing, legal, & other professionals throughout the organization;
Provide regulatory guidance to management, customers and staff as required;
Managing the training and compliance functions to achieve best practice results in line with agreed objectives and budgets.
Qualifications/Experience:
Thorough knowledge of domestic and international quality management system regulations for active implantable medical devices;
Bachelor's degree in Engineering or technical discipline and at least 5 years experience in the QA/QC functions within the medical device industry;
Ability to communicate and establish sound working relationships with people in a wide variety of discipline and backgrounds is important;
Hands-on experience with ISO 13485:2003 and FDA Quality Systems Regulations;
Demonstrated experience interfacing with regulatory agencies;
Excellent written and oral communication skills;
Attentive to detail, yet able to maintain a broad perspective.
To be part of this exciting life changing technology submit your application by clicking on the “Apply� button below. Please stipulate clearly which position you are applying for.
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Cheers dma
VCR
ventracor limited
For Australia Europe and the USA.........Quote:Job 1 of 1Listed...
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