Quality Assurance Engineer – Medical Devices


Your New Company

Vitrafy Life Sciences is an Australian based, globally oriented Life Sciences business, focused on the advancement of biomedical cryopreservation.

This dynamic, cutting-edge business is currently experiencing an exciting period of growth and development and is looking for an experienced Quality Engineer to join its close-knit Ballarat operation.

What You’ll Be Doing

Reporting to the Team Leader Quality & Regulatory and working in close collaboration with the Technical and Clinical teams, the Quality Engineer utilises Quality Assurance techniques and expertise to provide functional and regulatory support for new technologies and medical devices in line with Vitrafy Life Sciences’ strategic objectives and in accordance with industry standards and regulatory requirements.

This position is also responsible for providing direction on the quality aspects of technical documentation creation and design control activities, including risk management, verification and validation.

The Right Person

Essential

  • An entrepreneurial spirit and the desire to be a part of an innovative business
  • Tertiary Qualifications in Science, Engineering, Biotechnology, Biological Sciences, or equivalent qualifications
  • 3+ years’ experience in a quality function in the Medical Devices Industry
  • Proven experience with ISO 13485 
  • Proven experience in design control and the creation of medical device technical documentation
  • Proficiency with Microsoft Word, Excel, and Outlook

Desirable

  • Strong knowledge of GMP and regulatory requirements for Australia, Europe and USA 
  • Experience in medical device software development and validation
  • Knowledge of statistical quality techniques
  • Project management experience
  • Use of controlled electronic documentation systems

The Benefits

  • The chance to elevate your career in a cutting-edge business
  • High level of autonomy and a chance to truly make the role your own
  • Long-term career development opportunities

This position also offers an exciting tree change opportunity in picturesque Regional Victoria, with the chance to enjoy a good work-life balance and a rewarding lifestyle. 

To learn more about Ballarat and all that it has to offer, please visit www.ballarat.com.au

The Next Steps

Don’t miss this unique opportunity to take your career to the next level and make your mark in a business where your efforts will be truly recognised and rewarded. 

For further details contact Zoë Allan at Milano Partners on 0417 558 531

Applications Close: 5pm Friday, 19 August 2022.

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