i-Pharm Consulting

Supplier Quality Engineer

Location
Melbourne
Salary
Negotiable
Posted
28 Nov 2018
Closes
25 Dec 2018
Ref
#11572
Contract Type
Permanent
JOB TITLE

Supplier Quality Engineer –– Victoria based



JOB SUMMARY

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.



ROLE/DESCRIPTION

* 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

REQUIREMENTS

* 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.

www.i-pharmconsulting.com

TO APPLY

If you would like to discuss this vacancy further, please call Senior Consultant, Tom Desborough on +61 (0) 2 8310 5843, or email tdesborough@i-pharmconsulting.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.



KEY WORDS

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.

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