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May

Senior Quality Engineer - Medical Device R&d Australian Company

PharmiWeb.Jobs - Sydney, NSW

Engineering
Source: uWorkin

JOB DESCRIPTION

Job Title

Senior Quality Engineer - Sydney based

Job Summary

A Senior Quality Engineer is required for a small but growing medical devices company building their global R&D operation from Sydney. They have manufacturing on site.

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.

This will be a lynchpin role to support the head of quality.

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, Medsafe and ideally the FDA
  • 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 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 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.

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