QA Officer

Our client is an international Medical Device organisation who are a household name across various specialty and product areas. They offer fantastic training and onboarding and there are plenty of opportunities for career development and progression within the organisation.

Position Overview:

This position has been newly created for an additional member of the team to assist in the QA department. This role reports into the QA/RA Manager and is a full time permanent position. 

Responsibilities:

• Support the maintenance of the quality system to meet all applicable requirements for medical device/IVD business, e.g. 21 CFR 820, ISO 13485 & EU MDR/IVDR.
• Conduct tasks in support of NC, CAPA, record management, document controls, training.
• Review and approve routine batch records for product release.  With experience, will identify non-conformances and approve non-routine batch records.
• Support Senior Design QA Officer(s) on assigned tasks
• Conduct tasks in support of Design QA
• Collect and track design quality data, metrics and milestones for routine reporting, including Daily Management

Desired experience:

• Bachelor’s degree in science, medical or technical field 
• Experience in Quality Assurance, preferably medical device or IVD

What's on offer:

• Competitive Base salary + Super
• Hybrid work from home/office

 To apply for this role, please reach out to Nicola Davison on 0472 729 731

nicola.davison@onemd.com.au