JOB TITLE

Senior Quality Assurance Associate - Sydney based

JOB SUMMARY

A Senior Quality Assurance Associate is required for a mid sized global medical devices company. Their company culture is well known for being inspiring and energetic here in Sydney.

Hybrid WFH setup.

This will be a lynchpin role to support the head of quality assurance on all things quality including assembly. The role will be the next in line to the Director and need to be autonomous.

ROLE/DESCRIPTION
• Broad based Quality Engineering 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

REQUIREMENTS
• Life sciences degree (pharmacy preferred)
• Extensive experience in Australian Regulatory Affairs (and New Zealand ideally)
•... Experience with TGA and Medsafe.
• Auditor
• 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 Business Manager, Tom Desborough on +61 (0) 2 8310 5843, or email [email protected].

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 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
Australia

Salary Criteria