Quality Assurance Associate

Quality Assurance Associate

OncoRes Medical was founded at the intersection of medicine, science and humanity to improve the accuracy of breast-conserving surgery and eliminate the physical, psychological and economic burdens associated with repeat operations.

Our unique, informal culture champions vision, restlessness and humanity. Knowing we have an open and supportive team means each of us has the freedom to take responsibility and ownership. We have a shared passion to work restlessly, pioneering change to re-imagine the world, while remaining grounded in our commitment to science and quality.

Our passion for helping patients focuses us on the patient. We believe that all breast cancer patients deserve the opportunity to move beyond their breast cancer surgery knowing that all the cancer has been removed, the first time. In everything we do, we are thinking about how we can inch closer to a world free from re-excisions... We are going BEYOND BREAST CANCER.

Overview:

The Quality Assurance Associate at OncoRes Medical is a role responsible for supporting the successful and timely delivery of Quality Assurance projects and tasks across ongoing development and manufacturing activities.

If you want to use your expertise to help develop a novel, disruptive medical product that will impact the lives of millions of people around the world, get in touch This is a unique opportunity to get involved in an early, rapidly growing company with significant growth and development opportunities for the right candidate.

Duties:

Working alongside the Quality & Regulatory Affairs Manager, as a member of the Q & RA team; engage in a range of tasks with a focus on creating and maintaining an open dialogue with all staff to promote compliant engagement with the organization's Quality Management System (QMS):

• Developing and implementing quality control protocols and procedures.
• Assess efficiency and performance of established processes working towards implementation of improvement initiatives.
• Assist with clinical trial related quality and regulatory activities.
• Undertake regular internal auditing activities to ensure preparedness for external audits.
• Interact with the Q & RA Manager to ensure QA Processes at OncoRes Medical are compliant to all regulatory standards and consistent with QMS requirements.
• Collaborate with other teams to facilitate QMS compliance, including performing such tasks as root cause analysis, review of documents and resolving training issues.
• Contribute to Quality Assurance activities including assisting with Non-Conformances, Change Control, CAPAs, goods inspection and manufacturing activities.
• Analyse quality related data including non-conformances, maintenance activities, training and audit outcome, creating quality metrics to be reported to senior management.
• Facilitating quality assurance -related meetings and committees.
• Monitoring and resolving customer feedback and complaints.
• Ensuring compliance with legal and industry standards.
• Assist in QC tasks from time to time, as dictated by resources demands identified by the Q & RA manager.

Qualifications/Experience

• Relevant tertiary qualification in Engineering or Science.
• Experience operating within a quality-controlled manufacturing environment, preferably cGMP and/or ISO13485 Quality Management Systems.
• Personal Attributes: Ability to work in both collaborative and independent work situations and environments, must have excellent analytical and problem-solving skills.
• Communication skills: ability to effectively communicate through written and verbal means and constructively collaborate with colleagues is required.
• Task oriented: demonstrated knowledge and ability to plan, prioritize, and coordinate the completion of deliverables and tasks, must be flexible, have a hands-on approach and be willing to take initiative, bringing an enthusiastic 'can-do' attitude.
• Innovative: interest in innovation, ability to innovate and bring a 'solution focused' approach to solving problems, creating solutions to technical problems with an eye toward providing practical solutions in a timely manner.
• Professional: ability to remain professional and positive in all personal interactions, and provide an example of good work ethic, a willingness to help, and personal discipline in achieving goals.

Benefits:

• Comprehensive and competitive remuneration packaging including access to the employee stock ownership plan and phone allowance.
• A flexible and fun workplace where we understand that your life is more than your job.
• A rare opportunity to work closely alongside world-class colleagues and mentors with many collective years' of experience in all aspects of medical device development and commercialisation. All of us share a passion for working collaboratively where every voice is heard, and your personal and professional development is a high priority.

OncoRes is committed to building and fostering an inclusive, diverse workplace. We believe the differing perspectives and experiences each of us brings inevitably increases innovation and teamwork, flowing into positive tangible outcomes.

How to apply

Please apply online via SEEK and ensure you attach the following documents:

• Cover letter, addressing the selection criteria
• Resume

Applications close: Wednesday, 1 October 2025

This position is only open to applicants with relevant rights to work in Australia

If you have any queries in relation to this opportunity, please contact Georgina Holbeche ). Please note applications will not be accepted via this email address, only through SEEK.