Job 1 of 1Listed 18 Oct 2007
Work Type: Full Time Sub-Classification: Quality Assurance
Area: Sydney - North Advertiser: Private Advertiser
Senior QA Engineer - Data Specialist
Australian Publicly Listed Company.
International Medical Device 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 Intellectual Senior QA Engineer – Data Specialist to join our fast paced Quality Assurance team, reporting directly to the Vice President of Quality.
Ventracor is an Australian publicly listed company (ASX:VCR).
Key Challenges:
To critically assess and provide technical input into design verification and validation protocols and reports, including output specifications for mechanical circulatory support products;
Ensure statistically sound methodologies are applied to V&V protocols and testing of products throughout design and manufacturing and post-manufacturing phases;
To provide assistance in ensuring the technical content, accuracy and structure of documents generated as part of the design and manufacturing effort are robust and of the appropriate standard to meet external regulatory review;
To participate in project meetings and in design and manufacturing reviews to assess whether adequate evaluation has been performed in determining conformance to design input requirements and to assess whether critical/essential outputs and acceptance criteria are clearly defined;
To critically assess whether hazards have been identified and managed throughout the product realization process.
Qualifications and Experience:
Qualifications in Quality, Mechanical Engineering or Electrical Engineering;
Several Years experience in Quality, Reliability, R&D or Manufacturing engineering;
Competent in industry practices of validation, DoE
Strong proven skills in statistical application – examples including DOE, reliability, descriptive statistics, survival and algorithms;
Strong and clear communication skills;
Several years experience within a technical environment, including medical, defence and aerospace industries;
A good understanding of the requirements of FDA QSR, 93/42/EEC, ASTM etc. would be highly advantageous..
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.
Successful applicants will be contacted within 3 weeks of applying.
Email: Please click the 'Apply Now' button below
VCR
ventracor limited
Job 1 of 1Listed 18 Oct 2007Work Type: Full Time...
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