My client is a growing Australian-born MedTech company revealing unchartered territory utilising active implantable technology. Studies show that many seizures go undetected, and our mission is to improve treatment using previously unseen data.
For the patient, the system is minimally intrusive, and may offer an opportunity to collaborate with physicians about their care.
Complementing diaries, monitoring aims to provide physicians with more information to help with treatment.
The role reports into the Quality Director with dotted line report to the CTO.
You will be working with active implantable devices and heavily regulated medical device technology.
This role will be predominantly worked from home in either Sydney or Melbourne.
There will be travel to the US two times per year and a need to have site visits to Sydney monthly.
- Broad based Senior Quality Assurance 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.
- Design Controls including risk managing activities compliance
- Provide oversight on CAPA and NCR related activities
- Developing, implementing and managing the complaint handling process.
- Managing ongoing compliance with event management processes and providing support to the Epiminder team.
- Managing and improving the training system and training personnel.
- Working cross functionally with Engineering and Operation / Supply Chain
- Post-Market Surveillance and Production Activities
- Supporting Regulatory submissions in US and Aus
- ISO 62304 Software Compliance
- Minimum of 2 years working in quality assurance in Medical Device industry.
- Experience in ISO 13485 and FDA QSR
- Degree or higher qualification in scientific, engineering or other related discipline.
- Experience in and understanding of UDI regulations and implementation.
- Experience with manufacturing and post market surveillance
- Proficient in MS Office applications.
- High attention to detail, process minded.
- Proactive and keen to learn.
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.
If you would like to discuss this vacancy further, please call Executive Consultant, Tom Desborough on +61 (0) 2 8310 5843, or email email@example.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.