The RoleAs 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 requirementsAssist 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 proceduresAssist the management with preparing for internal and external auditsConduct regular product and protype testingAssist with planning and conducting necessary testing of new R&D in preparation for regulatory approval and market entryAssist with researching and compiling documentation required for regulatory listings and approvals of new R&D for Qlicksmart, and Qlicksmart's customersConduct and prepare market research reports and competitor analysis reports on a regular basisAssist the marketing team with focus group testing, reporting, and new launchesAssistance may be needed for other areas of workContribute effectively to the team and the company as a strong team playerWho You AreYou 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 details and strong project management skills. You will have tertiary qualification in biomedical engineering, bio medical 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 part-time basis. It is open to recent graduates and current masters and PhD students. Who we areQlicksmart 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 arrangementsAnnual stipend for work-related studiesCover annual fees for one professional body related to your area of workUp to 24 weeks of fully paid parental leave for the primary carer and up to 4 weeks of fully paid parental leave for secondary carerUp 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 treatment10 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 appointmentsAll 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 yearTwo additional leave days per year for volunteer work, offering an opportunity to give back to the community and providing community organisations with valuable assistance Please apply through SEEK with your cover letter and CV, or send to [email protected].