Supplier Quality Engineer
- Experience Level
- Experienced (non-manager)
Supplier Quality Engineer -- Victoria based
A Supplier Quality Engineer is required for a small but growing medical devices company building their global operation from Melbourne.
The company has recently had a large capital injection globally providing an exciting phase in their growth. There will be manufacturing and production on site.
- Broad based Quality Engineering role supporting management
- Manage vendor negotations
- Maintain Quality Management system in line with ISO13485, GMP
21CFR820 and other standards relevant to the design, development, manufacture and distribution of a product.
- Document Control
- Configuration Management
- Provide oversight on CA/PA related activates
- Life sciences degree (pharmacy preferred)
- Supplier Quality experience in any regulated industry
- Extensive experience in Australian Regulatory Affairs (and New Zealand ideally)
- Experience with TGA, Medsafe and ideally the FDA
- ISO 13485 knowledge
- People management would be a bonus
- Electronic QMS in a medical device setting
ABOUT i-PHARM CONSULTING
i-Pharm Consulting is a specialist Recruitment Company servicing the global Pharmaceutical industry. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.
If you would like to discuss this vacancy further, please call Senior Consultant, Tom Desborough on +61 (0) 2 8310 5843, or email email@example.com. If this role is not suitable, Tom is also available to discuss other possible positions or answer any general questions regarding your career and the current market.
Quality Engineer, Quality Manager, Senior QA Associate, Senior Quality Systems Associate, Quality Assurance Manager, Quality, MAA, CTA, Labelling, Regulatory Operations, Submissions/Documentation, QMS, CAPA, ISO 13485.