Quality Assurance and Regulatory Affair Associate

**Full-Time role at $65K per annum or Part Time role (3-4 Days) at $65k per annum based on your experience and qualifications.**

**When it comes to cancer care, choose hope.**
Chris O’Brien Lifehouse is an internationally recognised independent, not-for-profit cancer hospital leading the way in delivering patient-centered cancer care. It is one of only two comprehensive cancer centers in Australia, characterised by a concentration of world-leading cancer expertise and services in one facility, as well as leadership in clinical care, research, world-leading Biomedical Innovation Hub, and education. The Chris O'brien Lifehouse model of care is multidisciplinary, patient-centered, and research-based, delivered through integrated and co-located services including Australia’s largest You Can Centre for young people. We seek passionate, caring, and dedicated staff who align with our Founder’s vision of creating a collaborative environment in which, respect, discovery, empowerment, and nurture, thrive in the interests of our patients.
**Part-Time/Full Time - 12 months opportunity with the potential to be ongoing**
We are seeking a highly motivated Quality Assurance and Regulatory affair (QA&RA) personnel to assist the development and management of a Quality Management System (QMS) in-line with applicable global regulatory requirements and quality standards. The QA&RA Associate will work closely with Quality and Regulatory (Q&R) manager, Project Manager, and the Engineering team in the early phase of development and implementation of quality policies and procedures to facilitate relevant certifications and regulatory compliance at Chris O’Brien Lifehouse.
**About the Role**
The primary function of the QA&RA Associate role is to assist with the development, implementation, operation and ongoing maintenance of a new QMS at Chris O’Brien Lifehouse point of care manufacturing facility. This involves drafting of procedures, supporting QA and RA processes, and the implementation, monitoring and maintenance of these procedures. Where necessary, the QA&RA Associate will also provide support to other projects and activities where priority is required, which may involve utilizing analytical and problem-solving skills.
**About You**
- Attention to detail and accountability is essential
- Excellent communication skills: fluent English (oral & written) required
- Strong decision making and problem-solving skills
- Strong communication skills
- Excellent excel skills
- Keen to learn and enjoy working as part of a team.

**Main Tasks**
- To assist with drafting of documentation and implementation of QMS and QA &RA process towards meeting ISO13485:2016 standards and regulatory requirements.
- To assist with updating, maintaining and improving QMS process and documentation, once QMS is implemented.
- To assist with communications of quality related news, developing of training programs and conducting training.
- To assist with maintaining compliance to the established QMS for change controls, CAPA, deviations, complaints, internal and external audits, and associated documentation working closely with multiple stakeholders.
- To assist with the preparation of documentation for technical files and other documentation for TGA conformity assessment.
- Inspection of incoming materials for quality and meets established standards.
- To participate in product quality review and investigation process to resolve production issues to ensure that finished products meet end user requirements.
- To assist with product and process risk assessment process.
- To aid with development of CAPA plans and implement these within the timescale to eliminate the root cause of a non-conformance.
- To assist in ensuring all applicable standards are met in relation to regulatory and customer requirements.
- To provide an administrative support for Management Review meetings or quality meetings.
- To support the Q&R Manager and Project Manager with day-to-day duties, as required.

**Key Selection Criteria**:

- Tertiary education in a technical discipline (e.g Science, Engineering, Biomedical or related).
- Demonstrated understanding of principles of quality assurance and control.
- Minimum one year experience working in a quality assurance or quality related position. Experience supporting quality management in a medical device field is desirable.
- Attention to detail and excellent communication skills (verbal and written).
- The drive and determination for continuous improvement.
- Well-developed organizational skills and time management skills with the capacity to meet deadlines and effectively balance competing demands to meet set goals.

**Salary**: $65,000.00 per year