Senior Quality Manager - Medical Devices (BBBH34008) Western Sydney, Australia
| Salary: | AUD130000 - AUD140000 per annum + Superannuation |
About the company
A rapidly growing organisation and one of Australia’s leading suppliers of sterile and non-sterile medical consumables.
About the opportunity
The Senior Quality Manager role is a newly created position and reports into the Head of Quality. You will support and giude a team of quality professionals and be instrumental in shaping the Quality Management System for the manufacturing site.
Thorough knowledge of ISO 13485 in a sterile and non-sterile manufacturing environment is required in order to successfully review and update processes and systems.
Duties
- Provide guidance and education on Quality and Environmental Management Systems to co-workers and other stakeholders to drive continual improvement
- Identify and analyze potential events to eliminate risk related consequences
- Expand on strategic quality objectives to provide documented quality plans for current and future activities
- Provide practical education to team members on state-of-the-art QMS/EMS methodologies and techniques
- Manage the statistical processes required to enhance the KPI for the Quality team
- Contribute to the development, issue, amendment and control of the Manual and Systems to ensure continuing compliance with standards relevant to the goods manufactured and sponsored by the company
- Co-ordinating Management Review meetings and processes. Monitor progress and enforce required actions from the meeting
- Advise on quality and regulatory system improvements
- Participate in problem solving and other corrective action activities
- Undertake internal or external audits as required
Skills and Experience
- Tertiary qualification in a scientific or engineering discipline
- Demonstrated competency with ISO13485 and GMP requirements
- Minimum 5 years supervisory experience in an associated field and leadership qualities
- ERP systems proficiency
- Internal Auditing experience
- Solid analytical, planning, problem solving and organizational skills
- Innovative self-starter with excellent communication and interpersonal skills
How to Apply
Click apply or contact Joanna Murphy, Senior Recruitment Consultant on +61 2 8877 8718 for a confidential discussion.