About the company
VitalTrace Pty Ltd is a multi-award-winning, VC-funded Australian-based Med-tech start-up company aiming to improve outcomes for mothers and children during the childbirth process. We are doing this by developing novel cutting-edge biosensor technologies for fetal monitoring during childbirth. We believe that mothers and babies deserve the highest standard of care, and that childbirth monitoring should be accurate and allow clinicians to make informed and timely decisions. We have a vibrant culture with a diverse, high-performing multidisciplinary team of clinicians, researchers, engineers, chemists, software developers, and data scientists all working towards the same goal.
About the role
The Quality and Validation Specialist supports all validation and quality assurance activities associated with the development and manufacturing of biosensor technologies. Key responsibilities include executing and maintaining the Validation Master Plan (VMP) including sterilisation validation activities, developing and optimising QC methods, supporting environmental monitoring, managing change control processes, and ensuring documentation compliance within the electronic QMS. The ideal candidate will be as follows:
What will you do?-Key responsibilities:
Validation Activities
• Define and coordinate the execution of the Validation Master Plan (VMP) for manufacturing operations, including outsourced sterilisation.
• Maintain, schedule, and update the VMP.
• Conduct process, equipment, and method validation (IQ/OQ/PQ).
• Perform and document risk assessments.
• Ensure compliance with ISO 13485, ISO 14971, ISO 11737 and ISO 11137
• Ensure validation documentation completeness.
Quality Control Method Development
• Develop, optimise and validate the QC analytical methods.
• Prepare QC-related SOPs and documentation.
• Ensure scientific robustness and regulatory compliance of QC methods.
• Support intellectual property protection for QC methods.
Environmental Monitoring
• Define and coordinate the execution of the Environmental Monitoring Program.
• Perform routine monitoring of environmental conditions.
• Analyse monitoring data and escalate deviations.
• Document environmental monitoring activities.
Change Control
• Lead the Change Control process with cross-team collaboration
• Review proposed changes for quality and validation impact.
• Ensure updates to controlled documents.
• Maintain Change Control records in the electronic QMS.
Problem Solving & Continuous Improvement
• Support investigations, root cause analysis and CAPA activities.
• Collaborate to address process variation.
• Promote strong scientific and documentation practices.
Ownership & Collaboration
• Ownership of Validation and Change Control activities with focus on timely deliverables
• Provide technical coaching on Validation and Change Control matters
• Collaborate with R&D, manufacturing, and regulatory affairs to embed quality/validation practices.
• Represent Quality & Process in cross-functional project reviews.
Data Analysis & Quality Monitoring
• Perform statistical analyses on QC and validation data.
• Organise and summarise quality data.
• Prepare technical reports.
Documentation & Quality System Support
• Maintain documentation within the electronic QMS.
• Support audit readiness.
• Assist in cross-disciplinary quality-related projects
What you will possess?-Qualifications
Qualifications/Licences/Certificates/Skills
* Bachelor's level qualification in Science, Engineering, or a related discipline.
* Minimum of 5 years' experience in quality engineering, quality systems, or quality/validation roles
* Experience with operating in a regulated environment and/or a medical device field, is highly desirable.
* Demonstrated understanding and experience in the execution of the scientific method.
* Ability to be highly methodical, well-organised, and detail-oriented while being able to communicate scientific results clearly to the team through written and verbal means.
* Demonstrated understanding and experience with data analysis tools and statistical methods and analysis.
* Ability to work independently across multiple projects and teams in a fast-paced, multi-disciplinary environment.
* Self-motivated individual who takes initiative and holds the highest scientific standards coupled with the ability to work in both a team environment and independently with minimal guidance.
* Experience dealing with quality problems and coordinating investigations is desirable.
* Strong project management and cross-team collaboration experience
* Strong time management and communication skills (verbal and written).
Additional information relevant to this position includes:
Due to the nature of the position and industry, there may be a requirement to work outside normal business hours. We may from time to time vary or modify your duties but only to those duties for which you have the skill and competence.
Women and Aboriginal and Torres Strait Islander individuals are encouraged to apply