An outstanding opportunity for an experienced Quality Engineer has arisen with an Australian medical device manufacturing business. Our client is an industry leader, supplying quality products to the healthcare industry. The Quality Engineer will join a talented team and report directly to the Quality Assurance Manager, ensuring compliance to the company QMS is met and providing critical support to an integral part of the business.
Duties include but are not limited to:
- Compose, update, and maintain SOPs and other protocol documents
- Validation activities for processes and equipment
- Oversee calibration and maintenance activities for equipment
- Collect, process, and analyse QA and QC data, and carry-out product approval releases
- Carry out product and packaging shelf life studies
- Participate in risk management, conducting internal audits, facilitate third party audits, and assist in hosting external audits
- Manage environmental monitoring of cleanroom and prepare associated reports
The Successful Candidate will possess:
- Tertiary qualification in science or engineering (or related)
- Minimum 3 years experience in a similar role within the medical device industry
- In-depth understanding of ethylene oxide sterilisation processes - ISO 1135 highly regarded
- In-depth understanding of ISO 13485, GMP and TGA regulations
- Analytical mindset, high attention to detail
- Excellent communication skills - Both written and verbal
- Competent with using computers
If this role sounds like you, then please apply with your CV and cover letter in WORD format (no PDFs).
Questions can be directed to Leah Creswick at Fuse Recruitment on 0478 193 170.