Biological & Biomedical Sciences (Science & Technology) As the Quality Assurance and R&D Assistant in a successful team, you will help cultivate and maintain a company culture of innovation, continual improvement and high-quality standards. You will play a vital role in developing and commercializing solutions to improve the wellbeing of patients and healthcare employees. You will also work closely with cross-functional team members and our external stakeholders to develop our knowledge base in regulatory compliance and successful introduction of new medical technologies.
The key accountabilities include: Assist in compiling and maintaining quality, purchasing, and R&D documentation pertaining to ISO 13485 certification and other GMP requirements Assist with reviewing and updating Quality Assurance and R&D documentation such as production records, suppliers' certificates, and product specifications Assist with company-wide document control and maintenance of quality operating procedures Assist the management with preparing for internal and external audits Conduct regular product and prototype testing Assist with planning and conducting necessary testing of new R&D in preparation for regulatory approval and market entry Assist with researching and compiling documentation required for regulatory listings and approvals of new R&D for Qlicksmart, and Qlicksmart's customers Conduct and prepare market research reports and competitor analysis reports on a regular basis Assist the marketing team with focus group testing, reporting, and new launches Assistance may be needed for other areas of work Contribute effectively to the team and the company as a strong team player Who You Are You are someone who wants to take charge of your own development, and have an enthusiastic approach to expand your knowledge in both quality management and commercialisation. You are capable of managing multiple tasks and effectively prioritising your work. Becoming a member of our team requires that you will be result-driven, with a high attention to detail and strong project management skills. You will have tertiary qualification in biomedical engineering, biomedical science, or a related field. Prior experience in research or quality documentation will be a plus.
You will have excellent written communication skills, particularly in technical writing, and the conceptual capabilities to identify and respond to changes in regulatory guidelines and quality standards. You will also be proficient in computing skills, especially in using Excel, Word, and Endnote.
This position is available for immediate commencement on a part-time basis. It is open to recent graduates and current masters and PhD students. Who we are Qlicksmart is an award-winning Australian company established in 1996 which specialises in developing, manufacturing, and distributing world-class medical devices. Our products are recognised globally as industry-leading devices and we are passionate about creating a safer working environment for all healthcare workers. Our success is built on innovation, determination, and diversity. As such you will be part of a friendly, enthusiastic, and collaborative team which prides itself on a culture of mutual respect and inclusivity.
We are strongly committed to equal opportunity and continue to embed diversity and inclusion in all processes, from recruitment to assignments, from career management to recognition. Our Employee Benefit Program for permanent staff has a wide range of benefits , including:
Flexible working arrangements Annual stipend for work-related studies Cover annual fees for one professional body related to your area of work Up to 24 weeks of fully paid parental leave for the primary carer and up to 4 weeks of fully paid parental leave for secondary carer Up to 5 days of additional paid leave per calendar year for early pregnancy loss, termination of pregnancy or for time off for fertility treatment. Up to 2 days of additional paid leave per calendar year if your partner goes through early pregnancy loss, termination of pregnancy or for time off for fertility treatment 10 days of additional leave for essential and necessary gender affirmation procedures, which are often broadly defined to include medical, psychological, legal status and documentation amendment appointments All family leave entitlements are inclusive of LGBTQ people, regardless of the gender of the staff member or their partner The opportunity to purchase up to two weeks extra leave each calendar year Two additional leave days per year for volunteer work, offering an opportunity to give back to the community and providing community organisations with valuable assistance #J-18808-Ljbffr