Our client is a global healthcare company specialising in the manufacture of in-vitro diagnostic medical devices. An exciting opportunity has arisen for an experienced quality assurance professional to fulfil the role of Production Operator.
The Successful Candidate will have at least 3 years experience working in a highly regulated manufacturing environment, ideally within medical devices or pharmaceuticals. This is a permanent full-time role reporting to the Production Manager.
The Successful Candidate will possess:
- Minimum of 3 years experience working in a similar role, ideally within a medical device manufacturing environment
- Tertiary qualification in Science or related
- Strong understanding of ISO 13485 and GMP manufacturing standards
- Strong experience with carrying out internal and external audits
- Advanced user of Microsoft products - Word and Excel
- Excellent communication skills - Both written and verbal
- Excellent interpersonal skills
Duties and responsibilities will include (but not limited to):
- Follow approved manufacturing and testing instructions to produce a range of high quality IVD products
- Perform manufacturing and testing functions in line with requirements stipulated in SOPs, Manufacturing Batch Process Sheets and those defined in ISO13485 Quality Management Systems
- Follow manufacturing instructions to operate purpose-built equipment to dispense and pack finished products
- Perform in-process quality control tests using approved measuring and laboratory equipment
- Ensure the manufacturing facility and equipment are cleaned, organised and maintained in state commensurate with the requirements of the relevant SOPs
- Validation activities - Work with Validation Representative/ Production Engineers to assist in the validation and qualification of manufacturing equipment and processes
If this sounds like you, we'd love to see your application.
Please ensure applications are in Word format, not PDF.
Questions can be referred to Jaquline Farag at Fuse Recruitment Melbourne on 0411 832 205.