Job Description
What's in it for you?
- Join a company founded by surgeons, dedicated to innovation in sterile medical devices
- Be part of an ambitious team focused on continuous improvement and growth
- Part-time opportunity to engage in exciting opportunities as the business grows globally
The Company
Join a dynamic organization on the verge of significant growth, specializing in sterile medical devices and manufacturing processes. With a small current team they are gearing up for a major expansion, introducing their products through distribution partnerships and increasing their manufacturing capabilities. There is a big focus is on maintaining the highest quality standards while enhancing their processes.
The Role
As a Product Quality Engineer, you will be responsible for ensuring compliance with ISO 13485 and other relevant regulations. Key responsibilities include:
- Supporting the implementation and maintenance of the Quality Management System (QMS)
- Overseeing production by contract manufacturers and facilitating product releases
- Supervising in-house assembly and manufacturing processes, ensuring compliance with SOPs and batch release requirements
- Handling customer feedback and complaints, ensuring thorough documentation and timely resolution
- Managing non-compliance issues and developing quality control measures throughout production
- Participating in risk management activities and conducting QMS software validations
- Acting as a Document Controller, maintaining accurate records for compliance and audits
About You
- Bachelor's degree preferred (engineering background is a plus, but not essential)
- Experience with sterile medical devices, electronics, plastics, or manufacturing processes
- Knowledge of ISO 13485/9001 documentation and batch release expertise
- Strong interest in manufacturing and progression towards high-volume production
- Ambitious and technically minded, always looking for ways to improve processes and quality
What's on offer?
- Competitive salary and benefits package
- Opportunity for career growth as they expand into new markets and increase manufacturing capabilities
- A collaborative work environment with a focus on quality and compliance
If you are interested in this position or would like to arrange a confidential discussion, please contact Joe Cox, Recruitment Lead on +61(0)403 560 028
or email joe.cox@onemd.com.au
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