An outstanding opportunity for a mid-level experience QA Associate has arisen with a global leader in healthcare. We are seeking applications from candidates with strong experience working in a QA role within a medical device manufacturing environment.
Duties include but are not limited to:
- Compose, update, and maintain SOPs and other protocol documents
- Carrying out documentation activities such as GMP docs, quality manuals, DHFs, risk assessments, and batch records
- Validation activities for processes and equipment
- Carrying out investigations, and implementing CAPAs
- Collect, process, and analyse QA and QC data, and carry-out product approval releases
- Participate in risk management, conducting internal audits, facilitate third party audits, and assist in hosting external audits
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 ISO 13485 regulations and GMP standards
- In-depth understanding of TGA, FDA, Health Canada, and other relevant 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.