Be part of the change in medical prognosis for cancer patients. This innovative medical technology is at the commercialization stage and as it becomes more widely available you will see the positive impact it will have on patient lives.
You will be instrumental in shaping and maintaining the Quality Systems to ensure product compliance with regulatory standards.
About the company
An innovative medical device start-up company with a product at commercialization stage. They are dedicated to transforming cancer treatment and the prognosis of patients with limited options.
About the opportunity
Your role will be to ensure that quality documentation is prepared and maintained, in alignment with ISO 13485, country specific regulations, and company requirements and objectives.
This role will suit a Quality professional who is looking to reduce their hours from full-time or someone who is looking to return to work on a part-time basis.
The ideal person will be a proactive and intrinsically motivated individual who is passionate about advancements in healthcare.
- Ensure compliance with all corporate policies.
- Adhering to and maintaining all Quality Management System procedures and work instructions
- Processing contract manufacturer produced documentation, for example batch records and non-conformance reports within the QMS.
- Working independently to support registration activities and regulatory submissions in international markets.
- Maintaining global quality documents and standards in company database repository
- Supporting the Cross Functional team on special projects
- Reviewing artwork and packaging changes within limits of authority
- Supporting Internal audits
- Preparing and cross-checking technical documentation
- Company-wide training (regulatory and non-regulatory team members)
- Assisting in the maintenance and review of company procedures and forms to ensure compliance with ISO 13485.
Skills and Experience
- Bachelor's Degree qualified in science or engineering.
- Minimum of 5 years Quality Assurance experience in medical device company, or relevant scientific or technical industry
- Solid understanding of Quality Management Systems (ISO13485)
- Auditing certification is preferred.
- Intermediate to Advanced MS programs
- Strong organisational, analytical, and problem-solving skills.
- Ability to work on multiple projects both independently and in team environment.
A small team of professionals who are highly motivated, passionate about their work, and dedicated to ensuring the success of the product in cancer treatment.
How to Apply
Click apply or contact Joanna Murphy, Senior Recruitment Consultant on +61 2 8877 8718 for a confidential discussion.
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