Quality Specialist

6 months ago


Brisbane, Australia Brunel Full time

Brunel is currently partnered with a innovative medtech startup, based in the heart of Brisbane. This company has gone from strength to strength since it’s conception and has thrived off the foundation of industry experts. They are now searching for an additional Quality Specialist to assist with their portfolio expansion, following their partnership with a well-renowned global distributor. If you would like to be at the centre of innovation please see the role below:
**About this role**
- Administration & Oversight: Manage QMS processes including deviations, non-conformance reporting, CAPA, change management, supplier qualifications, validation, and risk management
- Regulatory Compliance: Ensure compliance with MDR (2020), ISO 13485, FDA's 21 CFR Part 820, and other relevant standards
- Quality Assurance: Monitor manufacturing performance, batch reviews, and post-market surveillance
- Support & Collaboration: Provide guidance for design, development, and product launch, collaborate with suppliers, and support continuous improvement
- Documentation & Training: Establish and update procedures, approve documentation, and conduct staff training
- Vendor Management: Qualify new vendors, maintain agreements, and review vendor performance
- Regulatory Support: Assist with lifecycle management of medical devices and maintain regulatory compliance
- Audit & Accreditation: Support internal audits, participate in audit activities, and maintain ISO accreditation and regulatory approvals

**About you**
- Min 3 years’ experience in a QA role
- Knowledge of cGMP, QMS, GXP and regulatory guidance’s to comply with regulatory bodies (FDA, TGA, EMEA)
- Experience with ISO 9001, ISO 13485, 21 CFR Part 820 and MDSAP
- Bachelor’s Degree and / or experience working in QA within medical devices, pharmaceuticals or another highly regulated industry
- Manufacturing, third party or supplier management experience
- Able to work independently
- Strong relationship building experience
- Experience with implants or orthopaedics desired

**Our offer**
- Opportunity to work in a fast-paced environment
- Great team culture Wage dependent on experience (approx.100,000)

**About us**
- Operating locally since 1997, Brunel has major bases of operation in Perth, NSW, Brisbane and Port Moresby, which are further backed by the strength and reach of a truly global network spanning over 45 countries, 120 offices and 45 years of successful operation._

Professional Bachelor


  • Quality Specialist

    7 months ago


    Brisbane, Australia Icon Group Full time

    **Nursing** **Brisbane** **Full Time** **Icon Group** **Quality Specialist** **Clinical Care - Quality and Risk Unit** **Icon Group, South Brisbane (Head Office)** The - Quality Specialist _supports and advises on patient safety topics including clinical incident management, Licencing and Accreditation, Infection Prevention and Control, consumer...

  • Quality Specialist

    3 months ago


    Brisbane, Australia Mable Full time

    **This role is for HomeMade - a related entity of Mable** HomeMade is a related entity to Mable and operate as a completely separate business, however both have a shared vision for self-management. We are a health-tech start-up established in 2020, focusing on transforming home care in Australia through our creative approach which is designed to support...

  • Quality Specialist

    7 months ago


    Brisbane, Australia StandardAero Full time

    We currently require an experienced Quality specialist to join our Quality Assurance department. Responsibilities will include: - Assisting the Quality Manager in the performance of Internal Audits and audits and inspections form outside parties and agencies - Resolving issues related to the quality of products and services - Supporting the QA manager in...

  • Clinical Governance

    6 months ago


    Brisbane, Australia Icon Group Full time

    **Quality and Safety** **Brisbane** **Part Time** **Icon Group** **Icon Group - Clinical Governance & Quality Specialist** 12 Month Contract Position, 3 days per week (24 hrs) The _Clinical Governance & Quality Specialist _supports and advises on patient safety topics including risk, clinical incident management, licencing and accreditation, infection...

  • Quality Specialist

    6 months ago


    Brisbane, Australia Evolve Scientific Full time

    Our client, a manufacturer North of Brisbane, are undergoing market expansion and currently seeking an experienced and motivated **Quality Specialist** for a **6-month assignment**. The role requires a self-motivated person with a will to succeed and a very hands-on approach. The company services many local customers and product lines. The role will be...

  • Clinical Governance

    6 months ago


    Brisbane, Australia Icon Group Full time

    **Nursing** **Brisbane** **Full Time** **Icon Group** **Clinical Governance & Quality Specialist** **Clinical Care - Clinical Governance & Quality Unit** **Icon Group, South Brisbane (Head Office)** The _Clinical Governance & Quality Specialist _supports and advises on patient safety topics including risk, clinical incident management, licencing and...


  • Brisbane, Queensland, Australia Brisbane Veterinary Specialist Centre Full time

    Role SummaryWe are seeking a highly skilled Radiation Oncologist to join our team at the Brisbane Veterinary Specialist Centre. As a specialist in veterinary radiation oncology, you will be responsible for providing expert care to our patients and contributing to the development of our radiation therapy services.About the RoleThe successful candidate will...


  • Brisbane, Queensland, Australia FCM Travel Full time

    Quality Assurance SpecialistFlight Centre Travel Group (FCTG) is a global travel retailer that opens up the world for those who want to see. As a Quality Assurance Specialist, you will play a key role in ensuring the quality of our mobile applications.As a member of our Digital Commerce team, you will define and improve processes, identify and mitigate...


  • Brisbane, Queensland, Australia Brisbane Veterinary Specialist Centre Full time

    We are seeking a highly skilled Veterinary Radiation Oncologist to join our team at the Brisbane Veterinary Specialist Centre in Brisbane, Queensland.Brisbane Veterinary Specialist Centre is a leading specialist veterinary hospital in Brisbane, Australia. We provide high-quality speciality care with compassion and have a strong focus on fostering innovation...


  • Brisbane, Australia Boeing RIV Site Full time

    We are currently recruiting for a Quality System Specialist to join our Brisbane-based Quality Team supporting the Joint Systems Programs in a part time role 2.5 days per week. **About Us** At BDA, diversity, inclusivity, and collaboration are central to our core values. Our interactions are shaped by the organisations cultural expectations and our team...

  • Clinical Governance

    6 months ago


    Brisbane, Australia Icon Group Full time

    **Quality and Safety** **Brisbane** **Full Time** **Icon Cancer Centre Australia** The _Clinical Governance & Quality Specialist _supports and advises on patient safety topics including risk, clinical incident management, licencing and accreditation, infection prevention and control, consumer engagement, and document management. The Clinical Governance &...


  • Brisbane, Queensland, Australia MPC Kinetic Full time

    About MPK: We are a dynamic energy company that is passionate about delivering high-quality solutions to our clients. With a proven track record of innovation and excellence, we have successfully delivered projects in upstream LNG development and servicing, fluid transportation, and renewables. Our long-term partnerships with major industry leaders...


  • Brisbane, Australia BOEING Full time

    At Boeing, we innovate and collaborate to make the world a better place. From the seabed to outer space, you can contribute to work that matters with a company where diversity, equity and inclusion are shared values. We’re committed to fostering an environment for every teammate that’s welcoming, respectful and inclusive, with great opportunity for...


  • Brisbane, Australia Toll Group Full time

    About Toll Group At Toll, we do more than just logistics - we move the businesses that move the world. Our 16,000 team members can help solve any logistics, transport, or supply chain challenge - big or small. We have been supporting our customers for more than 130 years. Today, we support more than 20,000 customers worldwide with 500 sites in 27 markets,...


  • Brisbane, Australia Asahi Beverages Full time

    **Your Impact** Embark on a compelling journey with Asahi Beverages! Don’t miss this exciting opportunity to join the quality team at our facility in Wulkuraka as a Quality Assurance Specialist. This role will see you responsible for the delivery of best-in-class quality processes, aligning your efforts with our broader business objectives for...


  • Brisbane, Queensland, Australia CPB Contractors Pty Limited Full time

    Role Overview">CBDG JV is seeking an experienced Senior Quality Assurance Specialist to join our team on the Cross River Rail project in Brisbane. This role will play a key part in ensuring the quality of our work and contributing to the delivery of this major infrastructure project.


  • Brisbane, Queensland, Australia Boeing Full time

    Job OverviewWe are seeking a Quality System Specialist to join our Brisbane-based team on a part-time basis. As a Quality System Specialist, you will play a key role in supporting the Joint Systems Programs and driving a continuous improvement culture within the programs.


  • Brisbane, Australia DVConnect Full time

    **_WE'RE HIRING_** **_ Full-time 6-month contract_** **_ Central Office Brisbane Location _** **Your Position** Quality & Training Specialists are responsible for the development and maintenance of appropriate clinical practice and service delivery through training, audit and other related quality functions. This role entails researching, designing, and...


  • Brisbane, Queensland, Australia GoSourcing Pty Ltd Full time

    OverviewGoSourcing Pty Ltd is seeking a skilled Senior Quality Assurance Specialist to support its Federal Gov't Department client in the ACT, QLD, and VIC offices.


  • Brisbane, Queensland, Australia Bupa Full time

    Bupa, a leading healthcare provider, offers an exciting opportunity for a motivated professional to join their team as a Healthcare Quality Specialist.About the RoleThis is a 3-day-per-week permanent position based at the Enoggera Health Centre. The successful candidate will be responsible for managing and maintaining the Quality Management System within the...