Quality Assurance Manager - Medical Technology - Sydney

Employer
i-Pharm Consulting
Location
Sydney, New South Wales, Australia / New South Wales, Australia
Salary
Negotiable
Closing date
22 Sep 2020

View more

Discipline
Quality
Hours
Full Time
Contract Type
Permanent
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JOB TITLE

Quality Manager - Sydney based - Full Time

JOB SUMMARY

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.

ROLE/DESCRIPTION

  • 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

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
  • 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.

www.i-pharmconsulting.com

TO APPLY

If you would like to discuss this vacancy further, please call Team Leader, 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.

Life Sciences recruitment is what we do.

We are an award-winning international life sciences recruitment company with offices in London, New York, Munich, Singapore and Sydney.  In a highly competitive market-place, we connect top talent with the very best opportunities.

 

Our clients include many of the most successful and innovative Pharmaceutical, Biotechnology, and Medical Devices companies, as well as a range of Contract Research & Manufacturing Organisations, Healthcare Agencies and Consultancies.

 

With offices across 3 continents, we have teams servicing the major global life science hubs. We combine local knowledge, with a global network of contacts that allows us to bring together talent and opportunity when it matters most.

Contact Us
  • 212 New King’s Road
  • London
  • SW6 4NZ
  • GB
  • +44 (0) 20 3189 2299
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