Quality Manager - Sydney based - Full Time
A Quality Manager is required for a medium sized consumerable medical devices company.
The company is going through some positive transition meaning they need a strong performer in this role. There will be manufacturing and production on site.
This role will be to support the head of quality.
- Broad based Quality Management role supporting management
- 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
- Support the Director of Quality Assurance
- Configuration Management
- Provide oversight on CA/PA related activates
- Line Management
- Life sciences degree (pharmacy preferred)
- 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
- Line Management
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 Team Leader, 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 Lead, Quality Manager, Senior QA Associate, Senior Quality Systems Associate, Quality Assurance Manager, Quality, MAA, CTA, Labelling, Regulatory Operations, Submissions/Documentation, QMS, CAPA, ISO 13485.