Quality Manager - NSW

Sector

RAQA

Type

Permanent

Contact

casey.duggan@onemd-od.com.au

Posted on

18-Dec-2025

Job Description

What's in it for you?
  • Be the Australian Quality lead for a growing organisation that has branched into local manufacturing
  • Work with truly life-changing products and a dedicated team

The Company
Our client is a well-known Medical Device company specialising in the life-changing specialty area of CMF. With standard instrument and implant kits as well as a comprehensive Patient-Specific offering, they have recently expanded their manufacturing capabilities and are looking for a Quality Manager to manage compliance, qualification / validation processes, quality assurance and complaints.

The Role
Looking to commence as soon as possible, the role encompasses Quality Management, Planning, Complaint Handling and Continuous Improvement.
In this role, you will be responsible for::
  • Management of specification documents (SOPs, WI) and compliance with these specifications
  • Participation in external and internal audits
  • Creation and maintenance of the Qualification / Validation Master Plan
  • Carrying out risk analyses
  • Planning, coordinating and recording all quality assurance measures
  • Ensuring proper recording of all complaints
  • Implementation / control of the root cause analysis
  • Planning, coordinating and monitoring improvement measure
  • Oversight into EHS with responsibility for risk management and compliance
  • Vendor validation
About You
  • Minimum 3 years’ experience in QM/QA in the medical device industry
  • In depth understanding and experience working within parameters of ISO 13485
  • Experience with eQMS preferred
  • Ability to effectively manage multiple projects and priorities
  • Demonstrated skills is MS-Office Suite, Adobe and SAP

If you’re looking for a fantastic new challenge for 2026 and want to join a company contributing to local manufacturing, get in touch!!

 
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