Quality Assurance Supervisor

2 weeks ago

Sydney, New South Wales, Australia Speedx Full time

**Location**: Sydney
**Work Type**: Permanent Full-time

**About us**:
At SpeeDx, we are passionate about improving patient outcomes and specialize in
molecular diagnostic solutions that go beyond simple detection to offer
comprehensive information for improved patient management. With our
headquarters in Sydney, our technology supports clinical diagnostic products for
infectious diseases with a range of products in the market and a pipeline of research
and In Vitro Diagnostic (IVD) assays since 2009.

Our well-equipped offices and laboratories are centrally located at the Australian
Technology Park in Eveleigh (Sydney) and are easily accessible by rail. SpeeDx
believes our employees are pivotal to our success and reputation, therefore we strive
to offer true work/life balance with opportunity for further training and structured
career development.

We like to recruit the best talent to join our growing company that was awarded 2021
Australian Company of the Year at the AusBiotech and Johnson & Johnson Innovation
Industry Excellence Awards. Make no mistake, we expect a lot from our people as
they do of us. So, if you can rise to the challenge, we will provide you with a dynamic
and rewarding career.

**About the Role**:

- **Permanent full-time** as a QA Supervisor
- Supervising QA & RA staff
- Maintaining the compliances of Quality Management System
- Developing quality and regulatory plans for new products
- Conducting surveillance audits internal and external as part of QMS
- maintenance- Working in an ISO 13485 accredited manufacturing environment

**Your primary responsibilities will involve but not limited to**:

- Establish and maintain a QMS compliant with ISO 13485 and other standards

and regulations as required
- Ensure the company achieves and maintain ISO 13485 design, development

accreditation and assist in extension of the scope
- Prepare quality and regulatory documentation and reports
- Works with senior management to ensure the company develops, achieves,
- and maintains the company's quality objectives- Organise and participate in external audits, liaise with regulatory and notified
- bodies as required- Conducting risk analyses by identifying critical points and preventive measures
- Validates quality process by establishing product specification and quality
- attributes- Maintain and improves product quality by conducting surveillance audit
- Prepare and compile technical files for the execution of TGA and CE Mark
- submissions- Maintain standards and regulatory oversight for SpeeDx
- Collaborate with other team members of management to develop new
- product designs- Develop quality in-house training for SpeeDx staff
- Up-to-date with new trends

**Qualifications/ Technical & Specialist Skills/ Experiences**:

- Minimum qualification of Bachelors in Science or Engineering
- Minimum 3 years' experience in quality or regulatory
- Experience in QMS ISO 13485, auditing, managing regulatory submission &
- liaising with regulatory body are essential- Regulatory experience in TGA, Health Canada, UKCA, US QSR & EU IVDR

regulations and additional relevant ISO standards are highly desirable

**Personal attributes/ Interpersonal skills**:

- Organised, detail oriented and self-motivated
- Strong analytical, writing and decision-making skills
- Excellent communication and management skills
- Ability to supervise and motivate team members
- Strong self-starter and self-motivated

  • Quality Assurance Supervisor

    2 weeks ago

    Sydney, New South Wales, Australia Titan America Full time

    **Overview**:Powhatan Ready Mix has an excellent opportunity for a **Quality Assurance Supervisor **in its Powhatan region located in Richmond, VA. This salaried non-exempt position reports directly to the Quality Assurance Manager. The primary function of this position is to ensure high-quality ready-mix products, provide industry-related technical...

  • Quality Assurance Supervisor

    2 weeks ago

    Sydney, New South Wales, Australia Be Campbell Full time

    Full time, permanent role with strong opportunity for career growth- Lead, mentor & motivate the team to deliver wholesome, quality food- Grow your food industry QA career with an industry leader**About the role**We are seeking a dedicated and experienced Quality Assurance Supervisor to join our Arndell Park team.In this role, you will be responsible for...

  • Quality Assurance Supervisor

    1 week ago

    Sydney, New South Wales, Australia Citr Full time

    Our client is committed to excellence in high-rise construction, including residential towers hotels and mixed-use developments.With a reputation for innovation and quality, the team is passionate about creating safe, sustainable, and aesthetically pleasing structures that enhance our communities.Position Overview:We are seeking a detail-oriented and...

  • Food Quality Assurance Officer

    2 weeks ago

    Sydney, New South Wales, Australia Feedwell Full time

    **Food Quality Assurance Officer - Monday to Thursday 4:00 PM to 12:00 AM**:**Schedule**: Monday to Thursday | 4:00 PM 12:00 AM | Sydney CBDJoin our thriving team and help us deliver consistently high standards in food production. At **Feedwell**, we're one of Sydney's fastest-growing corporate catering brands, serving esteemed clients like Google, TikTok,...

  • Experienced Quality Assurance Leader

    1 week ago

    Sydney, New South Wales, Australia beBeeQuality Full time $170,000 - $220,000

    Job OverviewWe are seeking an experienced Senior Quality Engineer Supervisor to lead our quality assurance efforts.This role will play a critical part in driving product excellence and compliance across various processes.The successful candidate will oversee a team of quality engineers, implementing strategies to enhance product quality and operational...

  • Quality Assurance

    2 weeks ago

    Sydney, New South Wales, Australia Snowy Hydro Careers Full time $104,000 - $130,878 per year

    Start Your Snowy Journey Join the Snowy 2.0 Owner's Team and play a key role in delivering Australia's largest renewable energy project. As a Quality Assurance Advisor, you'll ensure that every aspect of Snowy 2.0 meets project requirements and standards through the proactive delivery of quality assurance programs. Reporting directly to the Quality Assurance...

  • Quality Assurance Assistant

    2 weeks ago

    Sydney, New South Wales, Australia Fnt Bakery Full time

    Job Type: FlexibleReports to: Compliance DirectorPosition is Open to graduates and industry students.**About**FNT Bakery is dedicated to crafting high-quality, delicious baked goods for our community. We pride ourselves on using the finest ingredients and adhering to the strictest standards of production. We are passionate about baking and are looking for a...

  • Quality Assurance

    2 weeks ago

    Sydney, New South Wales, Australia Snowy Hydro Full time $104,000 - $130,878 per year

    Business Unit: Snowy 2.0Date: 23 Aug 2025Requisition ID: 441Start Your Snowy JourneyJoin the Snowy 2.0 Owner's Team and play a key role in delivering Australia's largest renewable energy project. As a Quality Assurance Advisor, you'll ensure that every aspect of Snowy 2.0 meets project requirements and standards through the proactive delivery of quality...

  • Quality Assurance

    2 weeks ago

    Sydney, New South Wales, Australia Mable Full time

    **Key Accountabilities**:- Develop and manage a comprehensive quality assurance program that meets industry standards, and legislation and enhances customer satisfaction.- Design and deliver technical training modules for new hires and ongoing training for existing staff to ensure high competence in handling customer queries and issues.- Conduct regular...

  • Quality Assurance

    2 weeks ago

    Sydney, New South Wales, Australia Snowy Hydro Pty Ltd Full time $104,000 - $130,878 per year

    Company description: Snowy Hydro is a dynamic, integrated energy business that has been providing on-demand, reliable energy to Australia for generations. Snowy Hydro owns and operates a powerful combination of generation assets, including the mighty Snowy Mountains Scheme, gas and diesel plants, and contracted wind and solar energy. We also provide...