Address OncoRes Medical Pty Ltd. in Nedlands, WA, is looking for a full time Quality Facilitator to join their team.
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 for 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.
DUTIES:
Working alongside the QA/RA Manager, and as a member of a QA/RA team, engage in any number of tasks deemed suitable for a Quality Assurance role including maintaining a dialogue with all levels of staff:
Developing and implementing quality control protocols and procedures.
Assess efficiency and performance of established processes working towards implementation of improvement.
Completion of service reports for the release of probes and workstations to the hospital for trials.
Undertake regular internal auditing activities to ensure preparedness of external auditing.
Work with the team towards the successful completion of all Quality Management System and ISO 13485 activities.
Interact with the QARA Manager to ensure QA Processes at OncoRes Medical are compliant to all regulatory standards and Quality Management System (QMS) requirements.
Collaborate on and review technical reports, quality assurance policies, operating manuals, records and work instructions.
Help to implement procedures for the company’s Electronic Resource Planning (ERP) manufacturing database including purchasing, vendor and inventory management, audit and approvals, batch and raw materials traceability, manufacturing record generation and maintenance, and warehouse management.
Contribute to Quality Assurance activities such as:
supporting manufacturing and QA/QC activities like batch/product release, in-process inspection, record maintenance and testing
goods inward and outward inspection activities, equipment maintenance and calibration
Non-Conformances, Change Controls and CAPAs
Analyse data related to manufacturing including non-conformances, maintenance activities and training.
Liase with senior management regarding quality metrics and auditing activities for the company.
Facilitating quality-related meetings and committees
CRITERIA:
At least a Bachelors degree or a minimum 5 years relevant experience
Strong spoken and written comprehension skills
Excellent analytical and problem-solving skills.
Experience operating within a quality-controlled manufacturing environment, preferably cGMP and/orISO13485 Quality Management Systems. Direct experience of QA or QC roles in such an environment would be desirable
Ability to innovate and bring a ‘solution focused’ approach to solving problems, creating solutions totechnical problems with an eye toward providing practical solutions in a timely manner
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.
A remuneration package between $70,000.00 – $90,000.00 per year plus superannuation is negotiable, depending on skills and experience.
Salary: Between $70,000 and $90,000
Job Type: Full Time
