Quality Assurance Associate
The Opportunity
As Vexev's Quality Assurance Associate, you will play a pivotal role in shaping our quality and regulatory frameworks, serving as a driving force to inspire our team toward efficient development while upholding exceptional standards of quality. You will work closely alongside an all-star multidisciplinary team of hardware and software engineers, scientists and clinicians, where we are building a technology that will become the new standard for vascular imaging to be used globally day-in-day-out. The successful development and rollout of the Vexev Ultrasound Imaging System will facilitate a shift in the approach to vascular imaging from reactive to proactive, saving millions of lives.
At Vexev, everyone takes ownership and pride to develop a high quality product, and so as our QA Engineer, you will aid our QA/Reg Lead, in fostering and strengthening this culture, providing guidance and assistance to the team. In this position, you will further enhance our existing QMS, utilising your expertise to steer product development in alignment with relevant standards, create and update SOPs and also prepare our regulatory submission for FDA clearance.
This role provides an opportunity to experience and be exposed to all aspects of product development and the quality assurance discipline. You will be welcomed as an integral part of the team and also empowered with a high level of autonomy to make thoughtful and pragmatic choices that shape the present and future of the company.
Working at Vexev
At Vexev we value creativity and collaboration above all else. There is no dress code, no meetings that don’t make sense, email is rarely used internally and you set your own start and finish time. We believe in working flexibly to suit your preferences, life stage, and family.
We are very serious about creating paradigm shifting solutions for vascular imaging, and as such have created a work environment where team members have autonomy, flexibility and minimal cognitive overhead with busy work that may take their minds off this mission.
As Vexev continues to grow and innovate, we encourage you to do the same, by providing ongoing opportunities to grow and make a real difference in people’s lives.
Our expansive HQ is located in Surry Hills - a 5 minute walk from Central station, and close-by to many great cafe’s, sandwich shops, fashion outlets and bars. Working at Vexev, you will find yourself in an office with plenty of space, natural sunlight, plants and fresh air throughout - as well as end of trip facilities (showers, bicycle storage, lockers etc) and a huge rooftop for team lunches and gatherings.
Vexev is well funded with backing by some of the best Australian and US based VC firms.
You will experience what it is like to be in the early stage of a company with exponential potential, closely collaborating with the top minds this industry has to offer.
The Role
Responsibilities
Guide and assist team members to facilitate understanding of, and compliance with quality standards, ISO 13485 and 21 CFR Part 820.
Maintain awareness of changes in regulations and standards that apply to the business, and work collaboratively with product development to execute projects in response to these changes.
Oversee documentation of design and development activities and reports as per the design and development plan and regulatory strategies.
Preparation of 510(k) application for FDA submission.
Work closely with engineering teams to translate team’s input into design control documentation.
Assist with general QMS maintenance and development activities to ensure QMS is fit for purpose and continually evolving with business needs, such as updating SOPs, creating NC-CAPA reports, quality form updates and change orders.
Execute post-market surveillance activities, and lead activities resulting from observations and non-conformances raised during internal audits and as part of CAPA investigations. Liaise with stakeholders and drive these findings to effective and timely closure.
Supporting and implementing significant quality projects across the business and creating and improving quality and business processes.
Conducting internal audits and assisting with external and supplier audits.
Must-Have Requirements
Tertiary Qualifications in Science, Engineering, Biotechnology, Biological Sciences, or equivalent qualifications.
Minimum 2 years’ in a Quality and/or Regulatory function, ideally in the Medical Devices Industry.
Proven experience with ISO 13485 and 21 CFR Part 820 requirements.
Proven experience in Design Control and the creation of Medical Device Technical Documentation.
Formal training and experience in Quality Systems audits.
Ability to think clearly and critically, assess information and evidence to make informed, timely decisions.
Strong written and verbal communication skills, organisational and prioritisation skills and high attention to detail.
Nice-To-Have Requirements
Prior experience with regulatory submissions or technical file compilation.
Experience with products that involve both hardware and software development.
Experience with Good Manufacturing Process (GMP)
Cultural-Fit Requirements
Thrives in uncertainty - comfortable upskilling and working from first principles.
Puts people first, is passionate about achieving results as a team.
Fired up about Vexev’s purpose! Wants to be a core part of our long term journey to improve lives with data-driven insights created by automated and accessible medical imaging solutions.
To Apply
Please complete our application form and we’ll be in touch with next steps! If you have any questions before you apply, feel free to email alexis@vexev.com
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We make hiring decisions based on your skills, experience, curiosity and passion. Here, we value and celebrate the diversity of perspectives, expressions and social and ethnic backgrounds. We deeply believe that these are key to creating a great place to work, and building an imaging device that is truly accessible to all.